Catalog Number

23038012

Brand Name

Sure-Vue

Version/Model Number

T3018-5555

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

-

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

GMP

Product Code Name

ANTISERA, CONTROL FOR NONTREPONEMAL TESTS

Public Device Record Key

c3cbc141-583d-4da6-8019-8a2ca4f2e8c9

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-