AccessGUDID - DEVICE: TheraBand Kinesiology Tape (00087453127478)

GUDID

Device Identifier (DI) Information

Brand Name: TheraBand Kinesiology Tape
Version or Model: 12747
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HYGENIC CORPORATION, THE

Primary DI Number: 00087453127478
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004163390 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
66337	Limb immobilization/support skin adhesive tape	A flexible band of fabric, plastic, or other material intended to noninvasively adhere to the skin surface to immobilize a joint and/or support a limb. It may be referred to as sports tape, functional tape, or kinesiology tape and is coated on one side with a pressure-sensitive adhesive and designed with a lower potential for producing an allergic reaction (i.e., hypoallergenic). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGX	Tape And Bandage, Adhesive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a cool, dark place

Clinically Relevant Size

[?]

Size Type Text
Width: 2 Inch
Length: 16.4 Feet

Device Record Status

Public Device Record Key: d65f8a51-216b-40ab-96cf-8562f06c70ce
Public Version Date: March 18, 2025
Public Version Number: 1
DI Record Publish Date: March 10, 2025