AccessGUDID - DEVICE: Tommie copper (00843041136433)

GUDID

Device Identifier (DI) Information

Brand Name: Tommie copper
Version or Model: 5008LD
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shenzhen Kaiyan Medical Equipment Co,. Ltd

Primary DI Number: 00843041136433
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 543062382 *Terms of Use

Device Description: Tommie copper Infrared &Red light contour therapy wrap

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:	No
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?
63381	Musculoskeletal infrared phototherapy unit, wearable	A patient-worn, battery-powered device assembly intended for use in the home or clinical setting to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., joint pain), and to improve blood circulation in these areas. It consists of a device with an integrated light with a controller; the light is intended to be attached to a specific body part (e.g., back, knee) and may include devices (e.g., adhesive pad) to allow attachment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILY	Lamp, Infrared, Therapeutic Heating

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: 5e9ded14-ced5-451d-81bd-75f44127684d
Public Version Date: April 18, 2025
Public Version Number: 2
DI Record Publish Date: January 26, 2022