Catalog Number

56-15934

Brand Name

Universal Neuro 3

Version/Model Number

56-15934

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

K151387,K151387

Product Code

HBW

Product Code Name

FASTENER, PLATE, CRANIOPLASTY

Public Device Record Key

8f529bf5-eaa2-49ec-82c6-30581c3dccbd

Public Version Date

July 01, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2015

Package DI Number

37613327090735

Quantity per Package

5

Contains DI Package

07613327090734

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack