AccessGUDID - DEVICE: Light-Smart Clothing Co. (00850056402446)

GUDID

Device Identifier (DI) Information

Brand Name: Light-Smart Clothing Co.
Version or Model: Cool Tangerine
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LUMITON MEDICAL PRODUCTS LLC

Primary DI Number: 00850056402446
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 126979200 *Terms of Use

Device Description: No description.

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?
60410	Musculoskeletal/physical therapy laser, home-use	An electrically-powered diode laser intended to provide noninvasive laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle pain, sports injury, rheumatism, disorders of the joints and soft/connective tissues), improvement of local blood/lymph circulation to facilitate healing/reduce swelling (e.g., lymphoedema therapy), or for non-needle acupuncture. It typically consists of a hand-held applicator designed for transcutaneous delivery of visible red/infrared laser light energy. It is intended to be operated by a patient/layperson in the home, typically under healthcare professional guidance.	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: 7b5eb165-69b0-425a-b549-94fc9fa0b253
Public Version Date: October 11, 2023
Public Version Number: 1
DI Record Publish Date: October 03, 2023