Device
Siegle Pneumatic Speculum (Otoscope) Complete With 3 Specula Ref:- OT-072-01 to OT-072-03 Stainless Steel
Manufacturer
SURTEX INSTRUMENTS LTD.
Model: OT-070-00 DI: 05055445967673 Status: New MRI: MR Conditional Single-use: No Rx: No OTC: No
First Published: 2026-05-12 Current Version: 2026-05-20
Description
Siegle Pneumatic Speculum (Otoscope) Complete With 3 Specula Ref:- OT-072-01 to OT-072-03 Stainless Steel
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: deafb7b6-c4e2-4a2b-903c-ee264e92556b
Distribution Status: In Commercial Distribution
DUNS Number: 216232502
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: No
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: 05055445967673
Type: Primary
Issuing Agency: GS1
GMDN
Code: 45085
Name: ENT diagnostic set
Definition:
A collection of battery-powered devices intended to be used by a physician to perform an ear/nose/throat (ENT) clinical examination on a patient. The devices are typically enclosed in a dedicated case and may include an ophthalmoscope, an otoscope, a pharyngoscope, a dedicated interchangeable handle that contains the batteries, which may be rechargeable and common to all the examination devices, different attachments (e.g., ear specula, mirrors, tongue depressors), spare parts (e.g., light bulbs), and may include a line-powered charging station (e.g., desktop, wall-mounted) to house/charge these devices. This is a reusable device that may contain some disposable devices.
FDA Product Codes
EPY
SPECULUM, ENT