Identity
- Trade Name
- Standard Supreme Mayo Cover FDA UDI
- Generic Name
- Patient surgical drape, reusable FDA UDI
- Device Name
- MAYO COVER STD SUPREME KAUMO 18X33 CEIL - NORMAN REG HLTH (RM 987802) FDA UDI
- Model / Reference
- 95268544 FDA UDI
- Description
- MAYO COVER STD SUPREME KAUMO 18X33 CEIL - NORMAN REG HLTH (RM 987802) FDA UDI
Identifiers
- Catalog Number
- 95268544 FDA UDI
- Primary DI / UDI-DI
- 00634916005318 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
Standard Supreme Mayo Cover 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 c5d48dfc-1ceb-44fa-8201-d0f65a2be039 36 fields · synced May 31, 2026