Identity
- Trade Name
- Regard™ FDA UDI
- Generic Name
- Non-woven gauze roll/sheet FDA UDI
- Device Name
- BANDAGE GAUZE 75X4IN RAYON POLYESTER STRETCH WEAVE STERILE LATEX FREE DISPOSABLE FDA UDI
- Model / Reference
- BAGA75X4RP-REG FDA UDI
- Description
- BANDAGE GAUZE 75X4IN RAYON POLYESTER STRETCH WEAVE STERILE LATEX FREE DISPOSABLE FDA UDI
Identifiers
- Catalog Number
- BAGA75X4RP-REG FDA UDI
- Primary DI / UDI-DI
- 10326053120135 FDA UDI
- FDA Product Code
- NAB FDA UDI
- GMDN Term
- Non-woven gauze roll/sheet 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: Non-woven gauze roll/sheet
Regard™ by Resource Optimization & Innovation, L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-woven gauze roll/sheet.
- Walgreens — WALGREEN CO. · Class I
- 16PW - Class A Burn Relief — Certified Safety Manufacturing, Inc. · Class I
- 16PW - Class A Blue Metal Detectable - Poly White — Certified Safety Manufacturing, Inc. · U
- EMT - Class B Trauma - Bag — Certified Safety Manufacturing, Inc. · Class I
- 36M - Class B Select - Metal — Certified Safety Manufacturing, Inc. · Class I
- 10PW - Oklahoma Gas & Electric - Poly White — Certified Safety Manufacturing, Inc. · N
- EMT - Duke Energy TD - Red Bag — Certified Safety Manufacturing, Inc. · Class II
- FAC-3 - Lawson Class B — Certified Safety Manufacturing, Inc. · N
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Resource Optimization & Innovation, L.l.c.
Sources (1)
- FDA UDI 0e8c2ac9-8e18-4edc-8a93-046ae4fa6235 34 fields · synced May 29, 2026