Catalog Number

-

Brand Name

Drive

Version/Model Number

RTLAGF-HP-LG

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

IRT

Product Code Name

PAD, HEATING, POWERED

Public Device Record Key

037a44bc-b448-4970-bd4b-1b612d2c64e8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 01, 2016

Package DI Number

10822383511174

Quantity per Package

6

Contains DI Package

00822383511177

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-