Identity
- Trade Name
- Omni-Tract® FDA UDI
- Generic Name
- Surgical retraction system, reusable FDA UDI
- Device Name
- Cloward Retractor, .5in x 3in (1.3cm x 7.6cm) FDA UDI
- Model / Reference
- 3914P FDA UDI
- Description
- Cloward Retractor, .5in x 3in (1.3cm x 7.6cm) FDA UDI
Identifiers
- Catalog Number
- 3914P FDA UDI
- Primary DI / UDI-DI
- 10381780274735 FDA UDI
- FDA Product Code
- FGN FDA UDIFFO FDA UDIGAD FDA UDI
- GMDN Term
- Surgical retraction system, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4730 FDA UDI878.4800 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical retraction system, reusable
Omni-Tract® by Integra Lifesciences Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Thompson — Thompson Surgical Instruments · Class I
- Thompson — Thompson Surgical Instruments · Class I
- GRACEY 14 TALON TOUGH QUIK TIP — American Eagle Instruments · Class I
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 |
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Manufacturer
- Manufacturer
- Integra Lifesciences Corp.
Sources (1)
- FDA UDI 0e380dd3-3997-4786-bd4d-3c68be7829b8 35 fields · synced May 31, 2026