AccessGUDID - DEVICE: Revian 2M USB to Magnetic Cable & Insert v2 Replacement Kit (00850003374130)

GUDID

Device Identifier (DI) Information

Brand Name: Revian 2M USB to Magnetic Cable & Insert v2 Replacement Kit
Version or Model: 10000-12722
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12722
Company Name: Revian, Inc.

Primary DI Number: 00850003374130
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080259941 *Terms of Use

Device Description: The Revian 2M USB to Magnetic Cable & Insert v2 Replacement Kit is a kit that may be shipped to users of the REVIAN Red device (Catalog # 10001) who have lost or misplaced their Magnetic Micro-USB Connector or Magnetic Cable originally supplied with the REVIAN Red Device.

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 [?]
K173729	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 15 and 35 Degrees Celsius
Storage Environment Humidity: less than 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 04e4cf98-1aef-4786-aee6-96f6817e1273
Public Version Date: February 24, 2025
Public Version Number: 4
DI Record Publish Date: April 06, 2024