Halyard - HYHL600 OS WRAP 36X36 - O&M HALYARD, INC.

Duns Number:081057389

Device Description: HYHL600 OS WRAP 36X36

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More Product Details

Catalog Number

62636

Brand Name

Halyard

Version/Model Number

62636

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 01, 2023

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

FRG

Product Code Name

Wrap, sterilization

Device Record Status

Public Device Record Key

d6076e1b-a729-4394-b86b-39a15857b19d

Public Version Date

January 21, 2021

Public Version Number

5

DI Record Publish Date

April 21, 2016

Additional Identifiers

Package DI Number

30680651626364

Quantity per Package

2

Contains DI Package

20680651626367

Package Discontinue Date

January 01, 2023

Package Status

In Commercial Distribution

Package Type

CS

"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