Catalog Number

-

Brand Name

Agee Digit Widget®

Version/Model Number

DWD-232

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)

Yes

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

K992970

Product Code

JDW

Product Code Name

Pin, Fixation, Threaded

Public Device Record Key

e9e9b248-cb1f-4d4d-872b-aaf2df69c81c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 23, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-