Catalog Number

18008337

Brand Name

DETECTABUSE

Version/Model Number

18008337

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DIF

Product Code Name

Drug Mixture Control Materials

Public Device Record Key

3c534f4f-94d4-4def-8186-3c7648b41b88

Public Version Date

May 04, 2021

Public Version Number

1

DI Record Publish Date

April 26, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-