Catalog Number

-

Brand Name

INVISx®

Version/Model Number

60100

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

K010361,K010361

Product Code

GXN

Product Code Name

PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Public Device Record Key

c4e5d2bd-63fa-4a95-98a9-9ba031989b72

Public Version Date

July 22, 2021

Public Version Number

5

DI Record Publish Date

July 16, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-