Device
Student Otoscope Set with Replaceable Specula and Extra Bulb
Manufacturer
Surgical Design, Inc.
Surgical Design, Inc.
Model: RT-182-SV
DI: 00810055257812
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-17
Current Version: 2026-05-25
Description
Student Otoscope Set with Replaceable Specula and Extra Bulb
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
97f905c3-8ce0-4286-bed0-1f2408e1f82c
Distribution Status:
In Commercial Distribution
DUNS Number:
112617522
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:
00810055257812
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 12849
Name: Otoscope, direct
Definition:
An electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head.
FDA Product Codes
HLJ
Ophthalmoscope, Battery-Powered