Pharmaceutical Innovations - TAC GEL Electrically Conductive Adhesive: 10 gm - PHARMACEUTICAL INNOVATIONS INC

Duns Number:067486548

Device Description: TAC GEL Electrically Conductive Adhesive: 10 gm tube

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More Product Details

Catalog Number

36-9000-10

Brand Name

Pharmaceutical Innovations

Version/Model Number

TAC GEL Electrically Conductive Adhesive

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

GYB

Product Code Name

Media, Electroconductive

Device Record Status

Public Device Record Key

e13fd24d-5c05-4ec1-b977-0114061b13f1

Public Version Date

October 22, 2018

Public Version Number

3

DI Record Publish Date

September 14, 2016

Additional Identifiers

Package DI Number

10300369000107

Quantity per Package

24

Contains DI Package

00300369000100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"PHARMACEUTICAL INNOVATIONS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 35