Catalog Number

TSCI-SIZ-NS

Brand Name

Terino Square Chin - Style I Sizers

Version/Model Number

TSCI-SIZ

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"

Yes

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

K902824

Product Code

FWP

Product Code Name

Prosthesis, Chin, Internal

Public Device Record Key

0ba5dc41-8029-404b-ac52-09a8b244c235

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-