Catalog Number

71062007

Brand Name

Jet-X

Version/Model Number

71062007

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

K093047,K093047

Product Code

KTT

Product Code Name

APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Public Device Record Key

0c3845ec-8844-433f-9a1b-f5c83ed15777

Public Version Date

February 17, 2022

Public Version Number

4

DI Record Publish Date

September 28, 2015

Package DI Number

23596010486626

Quantity per Package

12

Contains DI Package

03596010486622

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PKG