Catalog Number

-

Brand Name

DJO SURGICAL

Version/Model Number

803-42-44J

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

K190057

Product Code

FZX

Product Code Name

Guide, surgical, instrument

Public Device Record Key

f6e96e5b-fc64-4fdf-a5e3-4a948965c5e9

Public Version Date

August 21, 2019

Public Version Number

1

DI Record Publish Date

August 13, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-