Device
GL6030
Manufacturer
Zumax Medical Co., LTD
Model: GL6030 Catalog: 473-1810 DI: 06945095544050 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: No
First Published: 2026-05-21 Current Version: 2026-05-29
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 27e268ca-c9a4-49bf-8263-5de319ab8c32
Distribution Status: In Commercial Distribution
DUNS Number: 421348837
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 06945095544050
Type: Primary
Issuing Agency: GS1
GMDN
Code: 35906
Name: Endoscopic light source unit, battery-powered
Definition:
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.
FDA Product Codes
HJN
Transilluminator, Battery-Powered