Catalog Number

-

Brand Name

UNIVERSAL PLUS

Version/Model Number

UP14100-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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"

Yes

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

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

9f01fca4-ba35-41a8-9175-b3069c359191

Public Version Date

January 25, 2021

Public Version Number

1

DI Record Publish Date

January 15, 2021

Package DI Number

18056515880117

Quantity per Package

10

Contains DI Package

08056515880110

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-