Catalog Number

29920

Brand Name

Halyard

Version/Model Number

29920

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"

-

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

ILH

Product Code Name

SPLINT, HAND, AND COMPONENTS

Public Device Record Key

5ba05dc3-4e16-4563-9a79-4bc6fee2c19b

Public Version Date

November 26, 2020

Public Version Number

1

DI Record Publish Date

November 18, 2020

Package DI Number

30680651299209

Quantity per Package

10

Contains DI Package

10680651299205

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS