Catalog Number

PFS900000-00-00

Brand Name

NA

Version/Model Number

PFS900000-00-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

9af548ff-1d64-49ec-b30e-1f5bcb6f1bcb

Public Version Date

January 08, 2021

Public Version Number

4

DI Record Publish Date

March 06, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-