Catalog Number

636810

Brand Name

BioUniversal KF

Version/Model Number

636810

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 22, 2021

Issuing Agency

In HIBCC

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

EJT

Product Code Name

ALLOY, GOLD-BASED NOBLE METAL

Public Device Record Key

ac2ae9f2-e063-4fcd-96d1-3e78b8421476

Public Version Date

June 24, 2021

Public Version Number

3

DI Record Publish Date

January 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-