Catalog Number

16-1P3-9013

Brand Name

NeuroPro® Low Profile

Version/Model Number

16-1P3-9013

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GWO

Product Code Name

Plate, cranioplasty, preformed, alterable

Public Device Record Key

53baf84b-3f06-400e-a602-c2ec7a1a66f7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 06, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-