Catalog Number

-

Brand Name

Moi-stir 4 oz

Version/Model Number

1

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K810157,K810157

Product Code

LFD

Product Code Name

Saliva, Artificial

Public Device Record Key

41e583d2-9c5c-40bd-9353-6d39a28774bd

Public Version Date

September 28, 2022

Public Version Number

1

DI Record Publish Date

September 20, 2022

Package DI Number

00355299604836

Quantity per Package

12

Contains DI Package

00355299601040

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton