AccessGUDID - DEVICE: Performance Health PH MIXED TOWER DISPLAY (00087453135077)

GUDID

Device Identifier (DI) Information

Brand Name: Performance Health PH MIXED TOWER DISPLAY
Version or Model: 13507
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: HYGENIC CORPORATION, THE

Primary DI Number: 00087453135077
Issuing Agency: GS1
Commercial Distribution End Date: July 15, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 004163390 *Terms of Use

Device Description: TheraBand Kinesiology Tape Precut Roll- Beige/ Beige, TheraBand Kinesiology Tape Precut Roll- Black/ Gray, 3 hot/cold compress, gel, spray and roll-on.

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:	Yes
Combination Product:	Yes
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?
34832	Waterproof skin adhesive tape	A long and narrow flexible band that is coated on one side with a pressure-sensitive adhesive, and made from a material designed to resist water permeation, intended to be used to cover a surface (e.g., small wound), fix a dressing, attach objects, and/or exert pressure on a body part; it is not hypoallergenic. This is a single-use device.	Obsolete	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 16aaf8f8-c3f1-4e40-8f8d-69ad3d97655e
Public Version Date: October 23, 2019
Public Version Number: 2
DI Record Publish Date: July 15, 2019