Catalog Number

111619

Brand Name

NA

Version/Model Number

111619

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

Yes

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

-

Product Code

GAD

Product Code Name

RETRACTOR

Public Device Record Key

d8da908e-4fd9-4821-8ab3-44b8544278e3

Public Version Date

September 10, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

30848486016822

Quantity per Package

10

Contains DI Package

00848486016821

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack