Halyard - HYHL600 OS WRAP 54X72 - O&M HALYARD, INC.

Duns Number:081057389

Device Description: HYHL600 OS WRAP 54X72

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More Product Details

Catalog Number

62672

Brand Name

Halyard

Version/Model Number

62672

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

d0da7334-56b7-4bc2-9409-e1a0c1398d05

Public Version Date

January 20, 2021

Public Version Number

5

DI Record Publish Date

August 31, 2017

Additional Identifiers

Package DI Number

30680651626722

Quantity per Package

2

Contains DI Package

20680651626725

Package Discontinue Date

January 01, 2023

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