Catalog Number

-

Brand Name

Oral-Eze

Version/Model Number

SA96100

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

PJD

Product Code Name

Oral fluid drugs of abuse and alcohol test specimen collection device

Public Device Record Key

d629080a-f4c6-4d93-8955-191a7338c549

Public Version Date

July 22, 2021

Public Version Number

3

DI Record Publish Date

August 31, 2018

Package DI Number

30859952006261

Quantity per Package

25

Contains DI Package

10859952006236

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACKAGE