Catalog Number

-

Brand Name

Amerisource Bergen

Version/Model Number

10803

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"

Yes

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

MDM

Product Code Name

Instrument, Manual, Surgical, General Use

Public Device Record Key

6146a126-2287-4126-8c13-f3289ffa3527

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

November 18, 2021

Package DI Number

20368001108038

Quantity per Package

20

Contains DI Package

00368001108034

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box