Identity
- Trade Name
- SurgiTrackSM FDA UDI
- Generic Name
- First aid kit, non-medicated, single-use FDA UDI
- Device Name
- General Surgery Tray FDA UDI
- Model / Reference
- 4500480BF8 FDA UDI
- Description
- General Surgery Tray FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10885632077043 FDA UDI
- FDA Product Code
- LRO FDA UDI
- GMDN Term
- First aid kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: First aid kit, non-medicated, single-use
SurgiTrackSM by Owens & Minor Distribution, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Owens & Minor Distribution, Inc.
Sources (1)
- FDA UDI c287b7f3-c53e-42a1-b003-84ba868cfb74 33 fields · synced May 31, 2026