Catalog Number

mc6065

Brand Name

Avaline Medical NJ LLC

Version/Model Number

mc6065

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 25, 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

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

-

Product Code

FMH

Product Code Name

CONTAINER, SPECIMEN, STERILE

Public Device Record Key

52a6b630-99c3-4eb8-a480-e1a6079fb6ea

Public Version Date

January 26, 2022

Public Version Number

2

DI Record Publish Date

October 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-