Identity
- Trade Name
- Side Drape FDA UDI
- Generic Name
- Patient surgical drape, reusable FDA UDI
- Device Name
- Side Drape, 100% Polyester, Wrappel Body, Zorwik / Compel Pad, SIZE 36x72 FDA UDI
- Model / Reference
- 95901855 FDA UDI
- Description
- Side Drape, 100% Polyester, Wrappel Body, Zorwik / Compel Pad, SIZE 36x72 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00634916809404 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
Side Drape by Standard Textile Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Patient surgical drape, reusable.
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- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Lac-Mac — Lac Mac, Ltd. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
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 3962a9e3-f561-4a68-9dd2-8522c7d7cedb 35 fields · synced May 30, 2026