1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures. (UDI Z-0695-2018)
Manufactured by DePuy Mitek, Inc., a Johnson & Johnson Co.
Device Regulatory Overview
The 1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures. (Model/Catalog Number: Unspecified) is a medical device manufactured by DePuy Mitek, Inc., a Johnson & Johnson Co.. This product is indexed under FDA Product Code / Category Classification Lot codes: 138, 194, 633, 1067, 1741, 2576, 2608, and 2645 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
- N/A
- Product Code / EMDN
- Lot codes: 138, 194, 633, 1067, 1741, 2576, 2608, and 2645
- Device Name
- 1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures.
- Database Sync Date
- 2026-08-09 10:06:44
Full Regulatory Attributes
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{
"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 1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures.?
The registered manufacturer of record for 1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures. is DePuy Mitek, Inc., a Johnson & Johnson Co..
What is the Primary UDI-DI identifier for 1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures.?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-0695-2018.
What classification code is assigned to this device?
This device is registered under product classification code Lot codes: 138, 194, 633, 1067, 1741, 2576, 2608, and 2645.
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- → DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage: The Intermediary Tubing for FMS Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath, clamps, and a one-way valve. The FMS Outflow Tubing with One-Way valve is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy.
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