Device
Fiber Optic Light Guide Carrier, 3" (7.5 cm) Working Length
Manufacturer
Avalign Technologies, Inc.
Avalign Technologies, Inc.
Model: 72-401332
DI: 00190776420925
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
Fiber Optic Light Guide Carrier, 3" (7.5 cm) Working Length
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:
01f75064-1180-4171-bc77-0b09f02e9fc9
Distribution Status:
In Commercial Distribution
DUNS Number:
792528510
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:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00190776420925
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