Catalog Number

-

Brand Name

Battery Pack, Single Use, PDCMF, Tadiran

Version/Model Number

PDCMF-BP-001

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GEY

Product Code Name

Motor, Surgical Instrument, Ac-Powered

Public Device Record Key

b04d1a9d-b241-489e-90ef-b4b6e1469a81

Public Version Date

April 11, 2022

Public Version Number

1

DI Record Publish Date

April 01, 2022

Package DI Number

10856482008280

Quantity per Package

20

Contains DI Package

00856482008283

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-