Halyard - Surgical Gowns with Huck Towels - O&M HALYARD, INC.

Duns Number:081057389

Device Description: Surgical Gowns with Huck Towels

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


More Product Details

Catalog Number

-

Brand Name

Halyard

Version/Model Number

90138

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FYA

Product Code Name

GOWN, SURGICAL

Device Record Status

Public Device Record Key

8363b899-792f-454d-b699-7a3f76984ca2

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

March 15, 2017

Additional Identifiers

Package DI Number

30680651901386

Quantity per Package

36

Contains DI Package

10680651901382

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"O&M HALYARD, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 1044