Catalog Number

75611996

Brand Name

ComPel Surgical Gown

Version/Model Number

75611996

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K041539,K041539

Product Code

FYA

Product Code Name

Gown, Surgical

Public Device Record Key

de048c8a-ebd5-4dfe-9e08-e6bc43eb30d3

Public Version Date

November 08, 2021

Public Version Number

7

DI Record Publish Date

January 29, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-