Catalog Number

SELF136-01

Brand Name

Halyard

Version/Model Number

SELF136-01_0004

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

Yes

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

-

FDA Premarket Submission

-

Product Code

OGD

Product Code Name

Custom anesthesia tray

Public Device Record Key

356cc9e5-f8c3-4609-8651-f9953939ccd9

Public Version Date

March 09, 2021

Public Version Number

1

DI Record Publish Date

March 01, 2021

Package DI Number

20809160345983

Quantity per Package

20

Contains DI Package

10809160345986

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-