AccessGUDID - DEVICE: Wabbo Infrared Lamp (00816073022623)

GUDID

Device Identifier (DI) Information

Brand Name: Wabbo Infrared Lamp
Version or Model: 70500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70500
Company Name: HEALTH BODY WORLD SUPPLY, INC.

Primary DI Number: 00816073022623
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 061228290 *Terms of Use

Device Description: Model 70500 Wabbo Infrared Lamp is made from a famous heat lamp manufacturer in China. Floor Type Style Lamp is contents a replaceable heads with manual controller it's a durable and safety lamp with 5 plastic legs base. Sold by Each.

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):	Yes
Over the Counter (OTC):	No
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?
35147	Musculoskeletal infrared phototherapy unit, non-wearable	An electrically-powered device 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., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It may be available in a variety of forms however it is not intended to be worn on the body.	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: No 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: f0222dbb-7a9f-47e2-be9b-e3f26650ab91
Public Version Date: April 18, 2025
Public Version Number: 2
DI Record Publish Date: October 16, 2023