gudid
Primary ID: 6116-XS
SurgiMac (UDI 6116-XS)
Manufactured by Surgimac LLC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for SurgiMac - Primary ID 6116-XS
Device Regulatory Overview
The SurgiMac (Model/Catalog Number: 6116-XS) is a medical device manufactured by Surgimac LLC. This product is indexed under FDA Product Code / Category Classification OPJ within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 6116-XS
- Product Code / EMDN
- OPJ
- Device Name
- Blue Nitrile 300 ct. Extra Small. MaxSoft.
- Database Sync Date
- 2026-08-09 09:01:02
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 SurgiMac?
The registered manufacturer of record for SurgiMac is Surgimac LLC.
What is the Primary UDI-DI identifier for SurgiMac?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 6116-XS.
What classification code is assigned to this device?
This device is registered under product classification code OPJ.
Similar Classification Devices (OPJ)
Other Devices by Surgimac LLC
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