Catalog Number

92-34016

Brand Name

UNIVERSAL NEURO 3

Version/Model Number

92-34016

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K112557

Product Code

GWO

Product Code Name

Plate, cranioplasty, preformed, alterable

Public Device Record Key

12145bb1-85c6-4368-95b1-a443c50cf78d

Public Version Date

June 14, 2021

Public Version Number

5

DI Record Publish Date

August 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-