Identity
- Trade Name
- Sofsorb Drape FDA UDI
- Generic Name
- Patient surgical drape, reusable FDA UDI
- Device Name
- DRAPE SMALL DOCTOR 17X18 ALPIN - 1PLY SOFSORB HEMMED (SR18828) FDA UDI
- Model / Reference
- 95801618 FDA UDI
- Description
- DRAPE SMALL DOCTOR 17X18 ALPIN - 1PLY SOFSORB HEMMED (SR18828) FDA UDI
Identifiers
- Catalog Number
- 95801618 FDA UDI
- Primary DI / UDI-DI
- 00634916323979 FDA UDI
- FDA Product Code
- KKX FDA UDI
- GMDN Term
- Patient surgical drape, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Sofsorb Drape by Standard Textile Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Standard Textile Co., Inc.
Sources (1)
- FDA UDI 8a566584-6378-4d87-9eb7-e63b02dbbc9a 36 fields · synced May 30, 2026