Identity
- Trade Name
- Integra® FDA UDI
- Generic Name
- General surgical procedure kit, medicated FDA UDI
- Device Name
- Custom Procedural Tray FDA UDI
- Model / Reference
- 3405144 FDA UDI
- Description
- Custom Procedural Tray FDA UDI
Identifiers
- Catalog Number
- 3405144 FDA UDI
- Primary DI / UDI-DI
- 10381780266235 FDA UDI
- 510(k) Number
- K960248 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- General surgical procedure kit, medicated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Integra® by Integra Pain Management — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Integra Pain Management
Sources (1)
- FDA UDI b496f1c5-c3bc-4d35-b513-7c0e8ca4f234 38 fields · synced Jun 9, 2026