Identity
- Trade Name
- AmerisourceBergen FDA UDI
- Generic Name
- Radiopaque woven surgical sponge FDA UDI
- Device Name
- Laparotomy Sponges X-Ray Detectable pre-washed sterile 12" X 12" FDA UDI
- Model / Reference
- 11201 FDA UDI
- Description
- Laparotomy Sponges X-Ray Detectable pre-washed sterile 12" X 12" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00368001112017 FDA UDI
- FDA Product Code
- GDY FDA UDI
- GMDN Term
- Radiopaque woven surgical sponge FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4450 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Category: Radiopaque woven surgical sponge
AmerisourceBergen by Bp Pharmaceuticals Laboratories Unlimited Company — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Bp Pharmaceuticals Laboratories Unlimited Company
Sources (1)
- FDA UDI c0492e9f-19db-4fa6-833b-aaa6aeefa1d3 33 fields · synced May 30, 2026