Model: BM800
Catalog: 401E1020
DI: 06945095544296
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:
4b737345-3093-42b1-a408-acda42938216
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:
06945095544296
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 46790
Name: Indirect binocular ophthalmoscope
Definition:
An electrically-powered, head-worn, ophthalmic instrument designed to be held arm’s length from the patient to examine the interior of the eye and related structures [e.g., fundus (retina), cornea, aqueous, lens, vitreous] using the examiner’s two eyes simultaneously (stereoscopic vision). It is intended to provide a wide field of view and produce an inverted (reversed) image of approximately 2 to 5 times magnification. It typically consists of a main light to illuminate the interior of the eyeball, lenses, filters and an illuminator beam to eliminate reflexes; it can be mounted on a headband or spectacle frames.
FDA Product Codes
HLJ
Ophthalmoscope, Battery-Powered