← Back to catalogue

ComPel Surgical Gown

FDA UDI

Class II (US FDA UDI)

by Standard Textile Co., Inc.

Identity

Trade Name
ComPel Surgical Gown FDA UDI
Generic Name
Surgical gown, reusable FDA UDI
Device Name
OR GWN CMP NEG BK KAU BLU L/XL - RM (98-8282) MEMORIAL HERMANN FDA UDI
Model / Reference
75650514 FDA UDI
Description
OR GWN CMP NEG BK KAU BLU L/XL - RM (98-8282) MEMORIAL HERMANN FDA UDI

Identifiers

Catalog Number
75650514 FDA UDI
Primary DI / UDI-DI
00634916147629 FDA UDI
510(k) Number
K041539 FDA UDI
FDA Product Code
FYA FDA UDI
GMDN Term
Surgical gown, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4040 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

ComPel Surgical Gown by Standard Textile Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K041539 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Standard Textile Co., Inc.

Sources (1)

  • FDA UDI b5780413-56ae-4f1c-b6ef-20d925f9d14a 37 fields · synced Jun 8, 2026