Catalog Number

47634

Brand Name

Halyard

Version/Model Number

47634

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

K173942,K173942,K173942

Product Code

LZC

Product Code Name

Patient examination glove, specialty

Public Device Record Key

72cc9731-8e22-498d-b185-d250f319f243

Public Version Date

September 23, 2020

Public Version Number

1

DI Record Publish Date

September 15, 2020

Package DI Number

30680651476341

Quantity per Package

10

Contains DI Package

20680651476344

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS