Catalog Number

5701066

Brand Name

Henry Schein

Version/Model Number

5701066

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K122633,K122633

Product Code

LDJ

Product Code Name

Enzyme immunoassay, cannabinoids

Public Device Record Key

a5f7fb9a-dab0-4f74-abc2-0b27197f1217

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

November 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-