Identity
- Trade Name
- ComPel Surgical Drape FDA UDI
- Generic Name
- Patient surgical drape, reusable FDA UDI
- Device Name
- Utility Drape, 27x36 BLUE, 1-Ply Wrappel, 1-Ply 12x26 XTR Pad, - BARCODE 95-9026 (SR 11809) FDA UDI
- Model / Reference
- 95989835 FDA UDI
- Description
- Utility Drape, 27x36 BLUE, 1-Ply Wrappel, 1-Ply 12x26 XTR Pad, - BARCODE 95-9026 (SR 11809) FDA UDI
Identifiers
- Catalog Number
- 95989835 FDA UDI
- Primary DI / UDI-DI
- 00634916041972 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
- 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
Category: Patient surgical drape, reusable
ComPel Surgical Drape by Standard Textile Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 0b58a337-9793-47c0-8944-8251eb67a1b1 36 fields · synced May 30, 2026