AccessGUDID - DEVICE: SHARPER IMAGE (06975386540010)

GUDID

Device Identifier (DI) Information

Brand Name: SHARPER IMAGE
Version or Model: CH2-9
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CWT03106
Company Name: TAIZHOU YUNKAI TECH CO LTD

Primary DI Number: 06975386540010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 699495401 *Terms of Use

Device Description: 120V/60Hz 110W. CALMING HEAT WEIGHTED MASSAGING HEATING PAD. 3 Heat ,9 Vibration. This device complies with part 15 of FCC rules.

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?
62194	Electric pad localized-body heating system	An assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is intended for use in the home or a clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IRT	Pad, Heating, Powered

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: 60331607-40e2-4241-99fb-7d899394cddf
Public Version Date: June 23, 2022
Public Version Number: 1
DI Record Publish Date: June 15, 2022