Fornier Phantom Fiber(TM) Sutures: Item NumberDescription SMB0004254.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB0005255.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMP0004254.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMP0005255.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMSB01101PK PHANTOM FIBER SZ 2 WHITE SMSB0110N lPK BIOFIBER SUTURE SZ 2 WHT NEEDLED SMSB011210 PK PHANTOM FIBER SZ 2 WHITE SMSB0112N 10 PK PHANTOM FIBER SUTURE SZ 2WHT NEEDLED SMSB01201PK PHANTOM FIBER SZ 2 VIOLET SMSB0120NlPK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB012210 PK PHANTOM FIBER SZ 2 VIOLET SMSB0122N10 PK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB01301PK PHANTOM FIBER SZ 2 WHITE/VIOLET SMSB013210 PK PHANTOM FIBER SZ 2 WHITE/VIOLET Indications for use for the Phantom Fiber are: Phantom Fiber suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery. (UDI Z-1374-2018)
Manufactured by Tornier, Inc
Device Regulatory Overview
The Fornier Phantom Fiber(TM) Sutures: Item NumberDescription SMB0004254.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB0005255.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMP0004254.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMP0005255.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMSB01101PK PHANTOM FIBER SZ 2 WHITE SMSB0110N lPK BIOFIBER SUTURE SZ 2 WHT NEEDLED SMSB011210 PK PHANTOM FIBER SZ 2 WHITE SMSB0112N 10 PK PHANTOM FIBER SUTURE SZ 2WHT NEEDLED SMSB01201PK PHANTOM FIBER SZ 2 VIOLET SMSB0120NlPK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB012210 PK PHANTOM FIBER SZ 2 VIOLET SMSB0122N10 PK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB01301PK PHANTOM FIBER SZ 2 WHITE/VIOLET SMSB013210 PK PHANTOM FIBER SZ 2 WHITE/VIOLET Indications for use for the Phantom Fiber are: Phantom Fiber suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery. (Model/Catalog Number: Unspecified) is a medical device manufactured by Tornier, Inc. This product is indexed under FDA Product Code / Category Classification All lots within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
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- Product Code / EMDN
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- Device Name
- Fornier Phantom Fiber(TM) Sutures: Item NumberDescription SMB0004254.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB0005255.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMP0004254.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMP0005255.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMSB01101PK PHANTOM FIBER SZ 2 WHITE SMSB0110N lPK BIOFIBER SUTURE SZ 2 WHT NEEDLED SMSB011210 PK PHANTOM FIBER SZ 2 WHITE SMSB0112N 10 PK PHANTOM FIBER SUTURE SZ 2WHT NEEDLED SMSB01201PK PHANTOM FIBER SZ 2 VIOLET SMSB0120NlPK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB012210 PK PHANTOM FIBER SZ 2 VIOLET SMSB0122N10 PK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB01301PK PHANTOM FIBER SZ 2 WHITE/VIOLET SMSB013210 PK PHANTOM FIBER SZ 2 WHITE/VIOLET Indications for use for the Phantom Fiber are: Phantom Fiber suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
- Database Sync Date
- 2026-08-09 10:06:40
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Fornier Phantom Fiber(TM) Sutures: Item NumberDescription SMB0004254.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB0005255.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMP0004254.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMP0005255.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMSB01101PK PHANTOM FIBER SZ 2 WHITE SMSB0110N lPK BIOFIBER SUTURE SZ 2 WHT NEEDLED SMSB011210 PK PHANTOM FIBER SZ 2 WHITE SMSB0112N 10 PK PHANTOM FIBER SUTURE SZ 2WHT NEEDLED SMSB01201PK PHANTOM FIBER SZ 2 VIOLET SMSB0120NlPK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB012210 PK PHANTOM FIBER SZ 2 VIOLET SMSB0122N10 PK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB01301PK PHANTOM FIBER SZ 2 WHITE/VIOLET SMSB013210 PK PHANTOM FIBER SZ 2 WHITE/VIOLET Indications for use for the Phantom Fiber are: Phantom Fiber suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.?
The registered manufacturer of record for Fornier Phantom Fiber(TM) Sutures: Item NumberDescription SMB0004254.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB0005255.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMP0004254.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMP0005255.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMSB01101PK PHANTOM FIBER SZ 2 WHITE SMSB0110N lPK BIOFIBER SUTURE SZ 2 WHT NEEDLED SMSB011210 PK PHANTOM FIBER SZ 2 WHITE SMSB0112N 10 PK PHANTOM FIBER SUTURE SZ 2WHT NEEDLED SMSB01201PK PHANTOM FIBER SZ 2 VIOLET SMSB0120NlPK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB012210 PK PHANTOM FIBER SZ 2 VIOLET SMSB0122N10 PK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB01301PK PHANTOM FIBER SZ 2 WHITE/VIOLET SMSB013210 PK PHANTOM FIBER SZ 2 WHITE/VIOLET Indications for use for the Phantom Fiber are: Phantom Fiber suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery. is Tornier, Inc.
What is the Primary UDI-DI identifier for Fornier Phantom Fiber(TM) Sutures: Item NumberDescription SMB0004254.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB0005255.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMP0004254.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMP0005255.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMSB01101PK PHANTOM FIBER SZ 2 WHITE SMSB0110N lPK BIOFIBER SUTURE SZ 2 WHT NEEDLED SMSB011210 PK PHANTOM FIBER SZ 2 WHITE SMSB0112N 10 PK PHANTOM FIBER SUTURE SZ 2WHT NEEDLED SMSB01201PK PHANTOM FIBER SZ 2 VIOLET SMSB0120NlPK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB012210 PK PHANTOM FIBER SZ 2 VIOLET SMSB0122N10 PK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB01301PK PHANTOM FIBER SZ 2 WHITE/VIOLET SMSB013210 PK PHANTOM FIBER SZ 2 WHITE/VIOLET Indications for use for the Phantom Fiber are: Phantom Fiber suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-1374-2018.
What classification code is assigned to this device?
This device is registered under product classification code All lots.
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