Catalog Number

-

Brand Name

Antalgic Trak

Version/Model Number

AT1000

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

6b98fe72-e203-443a-a1aa-f924906f7daf

Public Version Date

November 30, 2018

Public Version Number

1

DI Record Publish Date

October 30, 2018

Package DI Number

00860000487511

Quantity per Package

1

Contains DI Package

00860000487504

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner pack