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ComPel Surgical Drape

FDA UDI

Class II (US FDA UDI)

by Standard Textile Co., Inc.

Identity

Trade Name
ComPel Surgical Drape FDA UDI
Generic Name
Patient surgical drape, reusable FDA UDI
Device Name
C-ARM COVER WRAPPEL 46X136 BLU - 2PLY WRAPPEL BLUE (SR 16159) FDA UDI
Model / Reference
95901385 FDA UDI
Description
C-ARM COVER WRAPPEL 46X136 BLU - 2PLY WRAPPEL BLUE (SR 16159) FDA UDI

Identifiers

Catalog Number
95901385 FDA UDI
Primary DI / UDI-DI
00634916263794 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

The ComPel Surgical Drape is a reusable non-invasive sheet designed to cover a portion of the patient's anatomy during surgery, serving as a barrier to cross-contamination. It is available in various designs and can be sterilized prior to use.

Cleared under the same submission

K923811 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Standard Textile Co., Inc.

Sources (1)

  • FDA UDI e03eeaf5-5c5a-4c66-b334-7a0f855b96c6 37 fields · synced Jun 23, 2026