Catalog Number

C-FORM10CC-OUS

Brand Name

CranioSculpt

Version/Model Number

C-FORM10CC-OUS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2021

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GXP

Product Code Name

METHYL METHACRYLATE FOR CRANIOPLASTY

Public Device Record Key

7e2e3bcf-18de-4e46-8082-baac00e73eb0

Public Version Date

March 22, 2021

Public Version Number

5

DI Record Publish Date

October 30, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-