Catalog Number

23200275

Brand Name

Sure-Vue

Version/Model Number

23-200-275

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KTN

Product Code Name

SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS

Public Device Record Key

0796dfec-40b4-4708-831b-f0f4eaaea7a1

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20613647000285

Quantity per Package

18

Contains DI Package

00613647000281

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case