AccessGUDID - DEVICE: MedX Rehab Portable Laser (00628451918233)

GUDID

Device Identifier (DI) Information

Brand Name: MedX Rehab Portable Laser
Version or Model: 0915
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MedX Health Corp

Primary DI Number: 00628451918233
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 202128257 *Terms of Use

Device Description: The MedX Rehab Portable Laser cluster-stand alone, LCS 450, delivers high-quality Low Level Laser Therapy (LLLT). The battery powered, hand-held device is utilized to treat a variety of conditions such as swelling, bruising, pain management, inflammation and many other conditions. The device utilizes three near infrared laser diodes and one visible blue LED that deliver LLLT therapy. The MedX Portable Laser has a power output of 450 mW, and a wavelength of 808 nm and has been designed for licensed or certified healthcare professionals.

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:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60409	Musculoskeletal/physical therapy laser, professional	An electrically-powered diode laser intended to provide non-surgical laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle/joint pain, sports injury), improvement of local blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It typically consists of a control unit which may be mounted on a mobile trolley, a foot-switch, and a connected applicator/beam guide designed for intra-orifice (e.g., intravaginal) or transcutaneous delivery of visible red/infrared laser light energy/heat. It is intended to be operated exclusively by a healthcare professional.	Active	false

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K032231	000

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
Storage Environment Atmospheric Pressure: between 700 and 1060 millibar
Storage Environment Humidity: between 20 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -4 and 149 Degrees Fahrenheit
Handling Environment Atmospheric Pressure: between 700 and 1060 millibar
Handling Environment Humidity: between 20 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 32 and 104 Degrees Fahrenheit

Clinically Relevant Size

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Size Type Text
Weight: 113 Gram

Device Record Status

Public Device Record Key: c34242f6-b36e-4719-9397-561c98d1a6e6
Public Version Date: December 08, 2022
Public Version Number: 11
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
70628451918232	7	00628451918233	2019-02-27	Not in Commercial Distribution	brown shipping carto
40628451918231	4	00628451918233	2019-02-27	Not in Commercial Distribution	shipping carton box
50628451918238	5	00628451918233		In Commercial Distribution	shipping carton box
30628451918234	3	00628451918233		In Commercial Distribution	shipping carton box
20628451918237	2	00628451918233		In Commercial Distribution	shipping carton box