Device
Endo-Plastic Scope 7" (175mm), 4mm diameter, 30°, wide angle, autoclavable
Manufacturer
Hayden Medical, Inc.
Hayden Medical, Inc.
Model: 405-450S
Catalog: 405-450S
DI: 00840319759011
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
Endo-Plastic Scope 7" (175mm), 4mm diameter, 30°, wide angle, autoclavable
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:
cf315188-7e93-446e-abdd-1bd8d89ba459
Distribution Status:
In Commercial Distribution
DUNS Number:
618214410
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00840319759011
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 37180
Name: Rigid optical sinoscope
Definition:
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the paranasal sinuses during an ear/nose/throat (ENT) intervention. It is inserted through a naris. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This is a reusable device.
FDA Product Codes
EOB
Nasopharyngoscope (Flexible Or Rigid)
Premarket Submissions
Submission Number:
K170285
Supplement Number:
000