Catalog Number

20200011

Brand Name

Salivabuse

Version/Model Number

20200011

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 06, 2020

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

DIF

Product Code Name

Drug Mixture Control Materials

Public Device Record Key

92a19c43-9852-4bfe-8a6a-aa67410e4e82

Public Version Date

August 07, 2020

Public Version Number

2

DI Record Publish Date

February 19, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-