AccessGUDID - DEVICE: Get Hair MD LaserCap (00850056575133)

GUDID

Device Identifier (DI) Information

Brand Name: Get Hair MD LaserCap
Version or Model: 00850056575133
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00850056575133
Company Name: LaserCap Company

Primary DI Number: 00850056575133
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 056706029 *Terms of Use

Device Description: Get Hair MD LaserCap

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?
47417	Hair growth laser device	An electronic, portable, head-worn or hand-operated device intended to be operated by a layperson affected by scalp hair loss (i.e., receding hairline/baldness due to androgenic alopecia) to stimulate hair growth on the scalp through the application of scheduled low-level laser therapy (LLLT). The device uses individual laser diodes to direct laser light at the scalp and may include features (e.g., a comb) to separate the user's hair to allow for improved penetration of the laser light. It is intended for use in the home or a clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAP	Laser, Comb, Hair

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K203826	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 Temperature: between -10 and 60 Degrees Celsius
Storage Environment Temperature: between 14 and 140 Degrees Fahrenheit
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8a18c273-b8da-4b68-9389-105f012f3690
Public Version Date: September 18, 2023
Public Version Number: 1
DI Record Publish Date: September 08, 2023