Catalog Number

55091

Brand Name

Halyard

Version/Model Number

55091

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

K102032,K102032,K102032,K102032

Product Code

LZC

Product Code Name

Patient examination glove, specialty

Public Device Record Key

3739cd35-5454-4932-8e3e-2f40b6872ec9

Public Version Date

November 23, 2020

Public Version Number

1

DI Record Publish Date

November 13, 2020

Package DI Number

20680651550914

Quantity per Package

50

Contains DI Package

10680651550917

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

DSP