Catalog Number

-

Brand Name

DJO SURGICAL

Version/Model Number

804-06-053

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

-

Prescription Use (Rx)

-

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

4e66914a-7cea-44e9-beec-50c55cdc56a4

Public Version Date

October 10, 2022

Public Version Number

3

DI Record Publish Date

August 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-