AccessGUDID - DEVICE: Kinesio Tex Gold BEIGE 2.5cm x 5m Elastic Therapeutic Tape (00850989002065)

GUDID

Device Identifier (DI) Information

Brand Name: Kinesio Tex Gold BEIGE 2.5cm x 5m Elastic Therapeutic Tape
Version or Model: GKT15014
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GKT15014
Company Name: Kinesio Holding Corporation

Primary DI Number: 00850989002065
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016287801 *Terms of Use

Device Description: Elastic Therapeutic Tape / Kinesiology Tape

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":	Yes
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?
34864	Adhesive bandage	A sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). 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: Avoid direct sunlight.
Storage Environment Temperature: between 10 and 30 Degrees Celsius
Special Storage Condition, Specify: Store in a cool dry place.
Special Storage Condition, Specify: Avoid extreme temperatures.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 5 Meters (16.4 feet)
Width: 5 Centimeter
Length: 5 Meter
Device Size Text, specify: 5cm (2 inches)

Device Record Status

Public Device Record Key: 29b233a1-6133-4e98-b961-ad2880c6b677
Public Version Date: July 04, 2023
Public Version Number: 1
DI Record Publish Date: June 26, 2023