Device
ELMED EOS HD PARANASAL SINUS ENDOSCOPE, 4MM DIA., 70 DEGREE VIEWING
Manufacturer
ELMED INCORPORATED
ELMED INCORPORATED
Model: 37400-70
Catalog: 37400-70
DI: 00198506090790
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
ELMED EOS HD PARANASAL SINUS ENDOSCOPE, 4MM DIA., 70 DEGREE VIEWING
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:
c7eb39f8-aac7-4cdd-bcb6-2f84da36b6fd
Distribution Status:
In Commercial Distribution
DUNS Number:
049290364
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:
00198506090790
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 37084
Name: Rigid endoscope telescope
Definition:
An optical device designed to provide the illumination and image transmission capabilities of a rigid endoscope. It typically includes a set of lenses (e.g., thin and rod-shaped lenses) and/or a fibreoptic bunch, and is introduced though the sheath of the endoscope (e.g., a rigid cystoscope or resectoscope). The endoscopic telescope is connected proximally to a light source, and the returning image is directly observed or scanned with a video camera. Dedicated types are available for direct, lateral, and oblique views. It is used for examination of body cavities following natural tracts (e.g., urinary, gastrointestinal) or surgical cavities (e.g., laparoscopic). This is a reusable device.
FDA Product Codes
LRC
Instrument, Ent Manual Surgical