Catalog Number

53605

Brand Name

Halyard

Version/Model Number

53605

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

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

IPM

Product Code Name

COVER, LIMB

Public Device Record Key

249e48ab-c8d5-4ea2-9979-e0a7ff979fde

Public Version Date

November 26, 2020

Public Version Number

1

DI Record Publish Date

November 18, 2020

Package DI Number

30680651536052

Quantity per Package

2

Contains DI Package

20680651536055

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS