Identity
- Trade Name
- Barrier Supreme Eye Drape FDA UDI
- Generic Name
- Patient surgical drape, reusable FDA UDI
- Device Name
- Barrier Supreme Eye Drape, 22x22, 1 Ply Softweave, 1 Ply Barrier Supreme 7x7 Reinforcement Pad, 3" Round Fenestration, Concealed Hems Around Fenestration and Reinforcement Pad, Hemmed All Around, QCM on Front Bottom Right Corner FDA UDI
- Model / Reference
- 96801654 FDA UDI
- Description
- Barrier Supreme Eye Drape, 22x22, 1 Ply Softweave, 1 Ply Barrier Supreme 7x7 Reinforcement Pad, 3" Round Fenestration, Concealed Hems Around Fenestration and Reinforcement Pad, Hemmed All Around, QCM on Front Bottom Right Corner FDA UDI
Identifiers
- Catalog Number
- 96801654 FDA UDI
- Primary DI / UDI-DI
- 00634916352641 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 Eye 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 22f287fb-995c-4f02-91ff-dc0c2eb2e7b0 36 fields · synced Jun 1, 2026