Catalog Number

-

Brand Name

Antalgic Trak

Version/Model Number

AT-100

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

-

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

K042482,K042482

Product Code

ITH

Product Code Name

Equipment, Traction, Powered

Public Device Record Key

453f2423-e216-41b8-88ad-85d66af16040

Public Version Date

November 29, 2019

Public Version Number

1

DI Record Publish Date

November 21, 2019

Package DI Number

00860000487542

Quantity per Package

1

Contains DI Package

00860000487528

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Each