Identity
- Trade Name
- ComPel Mayo Stand Cover FDA UDI
- Generic Name
- Patient surgical drape, reusable FDA UDI
- Device Name
- COMPEL LARGE MAYO STAND COVER - 26X61 2PLY-MERROWED (SR 11853) FDA UDI
- Model / Reference
- 27751552 FDA UDI
- Description
- COMPEL LARGE MAYO STAND COVER - 26X61 2PLY-MERROWED (SR 11853) FDA UDI
Identifiers
- Catalog Number
- 27751552 FDA UDI
- Primary DI / UDI-DI
- 00634916005578 FDA UDI
- 510(k) Number
- K923811 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
No
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
ComPel Mayo Stand Cover by Standard Textile Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K923811 also covers:
- ComPel Mayo Cover — STANDARD TEXTILE CO., INC.
- ComPel Surgical Drape — STANDARD TEXTILE CO., INC.
- ComPel Surgical Drape — STANDARD TEXTILE CO., INC.
- ComPel Surgical Drape — STANDARD TEXTILE CO., INC.
- ComPel Surgical Drape — STANDARD TEXTILE CO., INC.
- ComPel Surgical Drape — STANDARD TEXTILE CO., INC.
- ComPel Surgical Drape — STANDARD TEXTILE CO., INC.
- ComPel Surgical Drape — STANDARD TEXTILE CO., INC.
- ComPel Surgical Drape — STANDARD TEXTILE CO., INC.
- ComPel Surgical Drape — STANDARD TEXTILE CO., INC.
- ComPel Surgical Drape — STANDARD TEXTILE CO., INC.
- ComPel Surgical Drape — STANDARD TEXTILE CO., INC.
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 071c4509-e402-48f6-8b71-bf2c0e69d7a0 37 fields · synced May 30, 2026