Halyard - HALYARD,H400,STRWRP,-,40X40,150 - O&M HALYARD, INC.

Duns Number:081057389

Device Description: HALYARD,H400,STRWRP,-,40X40,150

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More Product Details

Catalog Number

68240-01

Brand Name

Halyard

Version/Model Number

68240

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

FRG

Product Code Name

Wrap, sterilization

Device Record Status

Public Device Record Key

06e552af-73cb-49f6-a9e2-d3974200fca0

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

March 02, 2016

Additional Identifiers

Package DI Number

30680651682407

Quantity per Package

3

Contains DI Package

20680651682400

Package Discontinue Date

-

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