Catalog Number

-

Brand Name

bioXtra

Version/Model Number

Oral Moisturizing Gel 15ml

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

K072306,K072306

Product Code

LFD

Product Code Name

Saliva, Artificial

Public Device Record Key

b5fd7783-edd6-4f15-be95-75df9a946524

Public Version Date

September 27, 2022

Public Version Number

1

DI Record Publish Date

September 19, 2022

Package DI Number

05425005127524

Quantity per Package

100

Contains DI Package

05425005127517

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton box