Catalog Number

2B8044

Brand Name

NA

Version/Model Number

2B8044

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NEP

Product Code Name

SYSTEM/DEVICE, PHARMACY COMPOUNDING

Public Device Record Key

1772665d-2c3d-41ac-a9d0-7ac357cfeedd

Public Version Date

June 30, 2022

Public Version Number

7

DI Record Publish Date

January 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-