Identity
- Trade Name
- Dupaque® FDA UDI
- Generic Name
- Radiopaque woven surgical sponge FDA UDI
- Device Name
- 4 in X 4 in H-Fold, 16-ply, 20 X 12 mesh gauze X-Ray detectable sponge. Banded in 5s. Sterilized. FDA UDI
- Model / Reference
- 9464S-5 FDA UDI
- Description
- 4 in X 4 in H-Fold, 16-ply, 20 X 12 mesh gauze X-Ray detectable sponge. Banded in 5s. Sterilized. FDA UDI
Identifiers
- Catalog Number
- DUP9464S-5 FDA UDI
- Primary DI / UDI-DI
- 00809958085721 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
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
No
FDA UDI
Category: Radiopaque woven surgical sponge
Dupaque® by Derma Sciences Canada, Inc — 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
- Derma Sciences Canada, Inc
Sources (1)
- FDA UDI c00f9b4c-b085-4ca7-b75c-af21052c1a2b 36 fields · synced Jun 1, 2026