ComPel MLR Surgical Gown - ComPel MLR Backless Pathology Gown, 1-Ply Front - STANDARD TEXTILE CO., INC.

Duns Number:006999858

Device Description: ComPel MLR Backless Pathology Gown, 1-Ply Front Aqua, 2-Ply sleeves, size XL

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

75673624

Brand Name

ComPel MLR Surgical Gown

Version/Model Number

75673624

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K041541,K041541

Product Code Details

Product Code

FYA

Product Code Name

Gown, Surgical

Device Record Status

Public Device Record Key

18353092-a8f8-4405-9096-f86892d5ecf7

Public Version Date

November 08, 2021

Public Version Number

4

DI Record Publish Date

April 03, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STANDARD TEXTILE CO., INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 26
2 A medical device with a moderate to high risk that requires special controls. 9