Catalog Number

-

Brand Name

Atlas Pro Driver Battery Pack, Sterile

Version/Model Number

APD-BP-001S-1

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

HWE

Product Code Name

Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Public Device Record Key

315efaeb-c477-49a1-ab4e-45e933ccac7c

Public Version Date

March 31, 2022

Public Version Number

3

DI Record Publish Date

March 13, 2020

Package DI Number

10856482008006

Quantity per Package

10

Contains DI Package

00856482008009

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-