Identity
- Trade Name
- Omni-Tract® FDA UDI
- Generic Name
- Surgical retraction system, reusable FDA UDI
- Device Name
- Torsion Clamp Assembly, 5/8in x 1/2in (1.6cm x 1.3cm) FDA UDI
- Model / Reference
- 3763 FDA UDI
- Description
- Torsion Clamp Assembly, 5/8in x 1/2in (1.6cm x 1.3cm) FDA UDI
Identifiers
- Catalog Number
- 3763 FDA UDI
- Primary DI / UDI-DI
- 10381780269779 FDA UDI
- FDA Product Code
- GAD FDA UDIFFO FDA UDIFGN FDA UDI
- GMDN Term
- Surgical retraction system, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI876.4730 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Omni-Tract® by Integra Lifesciences Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Integra Lifesciences Corp.
Sources (1)
- FDA UDI f752f2c7-0fa1-4fa4-a79f-85c409fdc76a 36 fields · synced Jun 8, 2026