Catalog Number

39712

Brand Name

ADC®

Version/Model Number

39712

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

KQW

Product Code Name

Goniometer, Nonpowered

Public Device Record Key

7f91c685-3b6c-4433-b572-dd0894cf6a62

Public Version Date

November 25, 2021

Public Version Number

2

DI Record Publish Date

July 31, 2020

Package DI Number

00634782899677

Quantity per Package

20

Contains DI Package

00634782098292

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner pack