Catalog Number

-

Brand Name

DigiFix

Version/Model Number

1146-0007

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

K132731

Product Code

JEC

Product Code Name

Component, Traction, Invasive

Public Device Record Key

2511a851-3368-4074-8ebb-df47dbc5854c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 02, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-