Identity
- Trade Name
- 635 - Certi-Gauze Roll - 4" x 6 yards - 1/Unit FDA UDI
- Generic Name
- Non-woven gauze roll/sheet FDA UDI
- Device Name
- 635 - Certi-Gauze Roll - 4" x 6 yards - 1/Unit FDA UDI
- Model / Reference
- R211-027 FDA UDI
- Description
- 635 - Certi-Gauze Roll - 4" x 6 yards - 1/Unit FDA UDI
Identifiers
- Catalog Number
- R211-027 FDA UDI
- Primary DI / UDI-DI
- 00766588110271 FDA UDI
- 510(k) Number
- K945002 FDA UDI
- FDA Product Code
- EFQ FDA UDI
- GMDN Term
- Non-woven gauze roll/sheet FDA UDI
Classification
- Device Class
- U 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Non-woven gauze roll/sheet
635 - Certi-Gauze Roll - 4" x 6 yards - 1/Unit by Certified Safety Manufacturing, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K945002 also covers:
- 634 - Certi-Gauze Roll - 2" x 6 yards - 2/Unit — Certified Safety Manufacturing, Inc.
- 637 - Certi-Gauze Pads - 3"x 3" - 4/Unit — Certified Safety Manufacturing, Inc.
- Certi-Gauze Pads - 2"x 2" - 25/Box — Certified Safety Manufacturing, Inc.
- Certi-Gauze Pads - 3"x 3" - 10/Box — Certified Safety Manufacturing, Inc.
- Certi-Gauze Pads - 3"x 3" - 100/Box — Certified Safety Manufacturing, Inc.
- Certi-Gauze Pads - 3"x 3" - 25/Box — Certified Safety Manufacturing, Inc.
- Certi-Gauze Pads - 4"x 4" - 25/Box — Certified Safety Manufacturing, Inc.
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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Certified Safety Manufacturing, Inc.
Sources (1)
- FDA UDI 032025d8-8198-4711-b408-72b52df8ac51 36 fields · synced May 30, 2026