Catalog Number

-

Brand Name

ALBAclone Anti-E

Version/Model Number

Z073U

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

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

-

Product Code Name

-

Public Device Record Key

cc788460-648a-48a0-a7a8-65a77b77534c

Public Version Date

March 31, 2022

Public Version Number

4

DI Record Publish Date

November 28, 2014

Package DI Number

05060242471315

Quantity per Package

3

Contains DI Package

05060242471469

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton