AccessGUDID - DEVICE: MedX Acupuncture Portable Laser (00628451918219)

GUDID

Device Identifier (DI) Information

Brand Name: MedX Acupuncture Portable Laser
Version or Model: 0912
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MedX Health Corp

Primary DI Number: 00628451918219
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 202128257 *Terms of Use

Device Description: The Acupuncture Portable Laser delivers high-quality auricular laser acupuncture therapy. The device features one GaAIAs near-infrared laser diode and three visible red LEDs and a special fiber optic light guide tip that deliver low level laser & light therapy to very small trigger points on the ear. The Acupuncture Portable Laser 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 [?]
K082707	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

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Storage and Handling
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: 190 Gram

Device Record Status

Public Device Record Key: ddd0ce7a-d3f2-47b5-ad8e-c375db0ad2be
Public Version Date: December 08, 2022
Public Version Number: 8
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 Status	Package Type
50628451918214	5	00628451918219	In Commercial Distribution	shipping carton box
30628451918210	3	00628451918219	In Commercial Distribution	shipping carton box
20628451918213	2	00628451918219	In Commercial Distribution	shipping carton box