TheraBand Kinesiology Tape - TheraBand Kinesiology Tape, Standard Roll, 2" x - HYGENIC CORPORATION, THE

Duns Number:004163390

Device Description: TheraBand Kinesiology Tape, Standard Roll, 2" x 16.4' - Blue/Blue Print, Tape and Bandage, TheraBand Kinesiology Tape, Standard Roll, 2" x 16.4' - Blue/Blue Print, Tape and Bandage, Adhesive

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More Product Details

Catalog Number

-

Brand Name

TheraBand Kinesiology Tape

Version/Model Number

12746

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

KGX

Product Code Name

Tape And Bandage, Adhesive

Device Record Status

Public Device Record Key

2509fe95-0e04-4c4b-9925-c0a6e9e0699f

Public Version Date

October 23, 2019

Public Version Number

2

DI Record Publish Date

October 09, 2018

Additional Identifiers

Package DI Number

30087453127462

Quantity per Package

24

Contains DI Package

00087453127461

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton

"HYGENIC CORPORATION, THE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 25
2 A medical device with a moderate to high risk that requires special controls. 1