Catalog Number

05889081160

Brand Name

PreciControl ISD

Version/Model Number

05889081160

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

JJT

Product Code Name

Enzyme controls (assayed and unassayed)

Public Device Record Key

7d0289e2-b0f2-4070-90b0-04f82688d88a

Public Version Date

February 14, 2019

Public Version Number

1

DI Record Publish Date

January 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-