Catalog Number

-

Brand Name

Samco™ Bio-Tite™ Wide Mouth, ST 120mL, 53mm, no lab, ORG Cap

Version/Model Number

070000

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

-

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

2e2f272a-3d79-4e47-a6ce-9bf48a657e26

Public Version Date

September 12, 2022

Public Version Number

1

DI Record Publish Date

September 02, 2022

Package DI Number

30850016060533

Quantity per Package

100

Contains DI Package

10850016060539

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case