Catalog Number

23038086

Brand Name

Sure-Vue

Version/Model Number

T3018-9005

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

b40af8a1-08ed-44a9-8e93-2be5e4b3abe1

Public Version Date

April 26, 2019

Public Version Number

1

DI Record Publish Date

April 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-