Device
FIBER OPTIC LIGHT CARRIER; 3.8MM X 2.5MM X 50CM, PILLING CONNECTOR
Manufacturer
ELMED INCORPORATED
ELMED INCORPORATED
Model: 42-P3.8X2.5X50
Catalog: 42-P3.8X2.5X50
DI: 00198506090424
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
FIBER OPTIC LIGHT CARRIER; 3.8MM X 2.5MM X 50CM, PILLING CONNECTOR
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
52436bf2-1356-4be1-a716-a7f8bd81691b
Distribution Status:
In Commercial Distribution
DUNS Number:
049290364
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
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:
00198506090424
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 43946
Name: Rigid optical laryngopharyngoscope
Definition:
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the larynx/oropharynx. It is inserted into the body through the mouth during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle, or the device may allow for direct visualization through the lumen of its shaft/working channel. This device may be equipped with a channel or mechanism allowing the introduction of air to prevent misting of the distal end. This is a reusable device.
FDA Product Codes
CCW
Laryngoscope, Rigid