Identity
- Trade Name
- Barrier Supreme Drape FDA UDI
- Generic Name
- Patient surgical drape, reusable FDA UDI
- Device Name
- Barrier Supreme Circumcision Drape, 1-Ply Barrier Supreme, 3x3 Reinforcement Pad, 1" Fenestration, Concealed Hems Around Fenestration and Reinforcement Pad, Hemmed All Around, 20x20 FDA UDI
- Model / Reference
- 96601662 FDA UDI
- Description
- Barrier Supreme Circumcision Drape, 1-Ply Barrier Supreme, 3x3 Reinforcement Pad, 1" Fenestration, Concealed Hems Around Fenestration and Reinforcement Pad, Hemmed All Around, 20x20 FDA UDI
Identifiers
- Catalog Number
- 96601662 FDA UDI
- Primary DI / UDI-DI
- 00634916354812 FDA UDI
- FDA Product Code
- PUI 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
Barrier Supreme 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Standard Textile Co., Inc.
Sources (1)
- FDA UDI c3e3419e-373c-4abb-9b48-7ecb0b2cd722 36 fields · synced May 30, 2026