Catalog Number

-

Brand Name

OralissTM Oral Fluid Drug Screen

Version/Model Number

DMDI-G812-005N

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

March 17, 2080

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

PUA

Product Code Name

Tenaculum, Uterine, Exempt

Public Device Record Key

13076465-5a5a-4eb7-b527-89c769fdbff7

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 17, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-