Catalog Number

ESEC-SIZ-NS

Brand Name

Silicone Sizer Set for ePTFE Extended Chin

Version/Model Number

ESEC-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"

-

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

K141027

Product Code

FWP

Product Code Name

Prosthesis, Chin, Internal

Public Device Record Key

82aa5e9d-3a5e-454e-9dd5-b0be61561308

Public Version Date

June 24, 2019

Public Version Number

1

DI Record Publish Date

June 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-