Catalog Number

3697Q

Brand Name

ADC®

Version/Model Number

3697Q

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

GWZ

Product Code Name

Percussor

Public Device Record Key

ac4275e0-9623-4e37-b80d-be6aa1574e94

Public Version Date

June 19, 2020

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

00634782536268

Quantity per Package

18

Contains DI Package

00634782036416

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case