Catalog Number

PHYS007-03

Brand Name

Halyard

Version/Model Number

PHYS007-03_0002

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KGX

Product Code Name

Tape and bandage, adhesive

Public Device Record Key

eaa8c0f1-79db-4848-b1ba-40e189ba0252

Public Version Date

December 21, 2020

Public Version Number

1

DI Record Publish Date

December 11, 2020

Package DI Number

20809160322052

Quantity per Package

50

Contains DI Package

10809160322055

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-