Catalog Number

-

Brand Name

IPS

Version/Model Number

60-000-60-09

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 09, 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

GXN

Product Code Name

PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Public Device Record Key

aa881f57-5f03-44c3-a7a2-e41de1971feb

Public Version Date

November 10, 2021

Public Version Number

7

DI Record Publish Date

November 25, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-