Catalog Number

171712

Brand Name

ClearFit

Version/Model Number

171712

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K170410,K170410

Product Code

GXN

Product Code Name

Plate, Cranioplasty, Preformed, Non-Alterable

Public Device Record Key

75dc6a7f-a85d-4bed-a3a0-abbf6c9fad98

Public Version Date

December 24, 2018

Public Version Number

1

DI Record Publish Date

November 21, 2018

Package DI Number

10855113008026

Quantity per Package

2

Contains DI Package

00855113008029

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case