Catalog Number

-

Brand Name

Drive

Version/Model Number

RTL10453

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

IPR

Product Code Name

CRUTCH

Public Device Record Key

7779e71b-6f1d-4420-bd89-c3d0033c9ac0

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 10, 2017

Package DI Number

10822383246403

Quantity per Package

8

Contains DI Package

00822383246406

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-