Catalog Number

-

Brand Name

Drive

Version/Model Number

RTL6121

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

FMR

Product Code Name

DEVICE, TRANSFER, PATIENT, MANUAL

Public Device Record Key

5aa420df-9ce2-4bd5-baeb-08e984b7009c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 10, 2017

Package DI Number

50779709061210

Quantity per Package

4

Contains DI Package

00779709061215

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-