Catalog Number

DB-C-C10CC

Brand Name

CRANIOSCULPT-C

Version/Model Number

DB-C-C10CC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K182742

Product Code

GXP

Product Code Name

Methyl Methacrylate For Cranioplasty

Public Device Record Key

bcdae69a-ac3b-40e6-8ed6-07ee41b7964e

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

June 09, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-