Identity
- Trade Name
- Regard™ FDA UDI
- Generic Name
- Radiopaque non-woven surgical sponge FDA UDI
- Device Name
- SPONGE GZE XRAY STRL LF 4X4IN 16PLY FDA UDI
- Model / Reference
- GASPG4X4P16X-REG FDA UDI
- Description
- SPONGE GZE XRAY STRL LF 4X4IN 16PLY FDA UDI
Identifiers
- Catalog Number
- GASPG4X4P16X-REG FDA UDI
- Primary DI / UDI-DI
- 10326053119986 FDA UDI
- FDA Product Code
- NAB FDA UDI
- GMDN Term
- Radiopaque non-woven surgical sponge FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4014 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiopaque non-woven surgical sponge
Regard™ by Resource Optimization & Innovation, L.l.c. — 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
- Resource Optimization & Innovation, L.l.c.
Sources (1)
- FDA UDI 2504a701-4803-4a5f-8d26-67381d3bb30d 34 fields · synced May 31, 2026