AccessGUDID - DEVICE: mytaMed (B351MVLLS4LBTP0)

GUDID

Device Identifier (DI) Information

Brand Name: mytaMed
Version or Model: mV-LLS-4LBTP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: mV-LLS-4LBTP
Company Name: Mytamed, Inc.

Primary DI Number: B351MVLLS4LBTP0
Issuing Agency: HIBCC
Commercial Distribution End Date: December 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 015903922 *Terms of Use

Device Description: Rover IV Portable LED Light Source Complete with Charger and Batteries

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):	No
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?
35906	Endoscopic light source unit, battery-powered	A battery-powered device designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities when using rigid or flexible endoscopes (e.g., laparoscopes, gastroscopes). It is typically designed as a portable endoscope attachment whereby the bright light is channelled to the endoscope to illuminate the site of observation/intervention while minimizing tissue heating. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCW	Light Source, Fiberoptic, Routine

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: Yes

Sterilization Method [?]
High-level Disinfectant
Hydrogen Peroxide

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: 3ceadb17-0189-4676-96cc-f9f6609a7573
Public Version Date: July 03, 2025
Public Version Number: 5
DI Record Publish Date: September 24, 2016