Catalog Number

-

Brand Name

Sterile Specimen Container

Version/Model Number

021038

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 28, 2022

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FMH

Product Code Name

CONTAINER, SPECIMEN, STERILE

Public Device Record Key

cec654c9-d71d-441d-8492-70dd2b30bea7

Public Version Date

August 09, 2022

Public Version Number

2

DI Record Publish Date

September 09, 2018

Package DI Number

37503025060089

Quantity per Package

3

Contains DI Package

57503025060083

Package Discontinue Date

July 28, 2022

Package Status

Not in Commercial Distribution

Package Type

Case