Catalog Number

-

Brand Name

AmerisourceBergen

Version/Model Number

11501

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LXG

Product Code Name

Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Public Device Record Key

04309128-c8f7-4732-9311-9ddf5f135e7e

Public Version Date

December 08, 2021

Public Version Number

2

DI Record Publish Date

March 03, 2021

Package DI Number

60368001115010

Quantity per Package

10

Contains DI Package

00368001115018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box