Catalog Number

36600

Brand Name

Halyard

Version/Model Number

36600

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

-

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

fe5d9a58-2b67-4b48-8721-fd620bf00bf1

Public Version Date

November 26, 2020

Public Version Number

1

DI Record Publish Date

November 18, 2020

Package DI Number

30680651366000

Quantity per Package

4

Contains DI Package

20680651366003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS