Identity
- Trade Name
- Sof-Rol® FDA UDI
- Generic Name
- Cotton wool roll, sterile FDA UDI
- Device Name
- SOF-ROL STERILE 5CM X 3.6MTR 20 FDA UDI
- Model / Reference
- 72345-10 FDA UDI
- Description
- SOF-ROL STERILE 5CM X 3.6MTR 20 FDA UDI
Identifiers
- Catalog Number
- 72345-10 FDA UDI
- Primary DI / UDI-DI
- 04042809438468 FDA UDI
- FDA Product Code
- ITG FDA UDI
- GMDN Term
- Cotton wool roll, sterile FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3025 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
Dimensions & Sizes
- Size
- Length — 360 Centimeter FDA UDIWidth — 5 Centimeter FDA UDI
Category: Cotton wool roll, sterile
Sof-Rol® by Bsn Medical, 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
- Bsn Medical, Inc.
Sources (1)
- FDA UDI 1dd5b549-7f2f-4a45-b35d-028b1248c4c8 36 fields · synced Jun 8, 2026