Catalog Number

250-124S

Brand Name

Anatomical Chin

Version/Model Number

Size 2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K944164

Product Code

FWP

Product Code Name

Prosthesis, Chin, Internal

Public Device Record Key

2822ba48-4d42-44e5-88a4-1989d9935ed7

Public Version Date

April 21, 2021

Public Version Number

1

DI Record Publish Date

April 13, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-