Home GUDID B382SD9200321070 Surgical Direct
Primary DI B382SD9200321070
Brand Surgical Direct
Company Surgical Direct, Inc.
Model SD920032107
Catalog number SD920032107
Device description Hartman Speculum, 6.5mm x 7mm, Oval
Published 2026-07-29
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name LRC Instrument, Ent Manual Surgical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LRC Instrument, Ent Manual Surgical Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B382SD9200321070 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Ear speculum, reusable A rigid plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may in addition be intended for use with an audiometer and might also be referred to as an ear cannula or probe. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 124367223 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00190776432263 Millennium Avalign Technologies, Inc. LRC 2026-09-24 00190776432270 Millennium Avalign Technologies, Inc. LRC 2026-09-24 00190776431440 Millennium Avalign Technologies, Inc. LRC 2026-09-22 00190776432140 Millennium Avalign Technologies, Inc. LRC 2026-09-22 00190776428020 Millennium Avalign Technologies, Inc. LRC 2026-08-27 00190776428174 Millennium Avalign Technologies, Inc. LRC 2026-08-27 00844505014762 BONE WAX APPLICATOR Grace Medical, Inc. LRC 2026-08-27 00190776427566 Millennium Avalign Technologies, Inc. LRC 2026-08-26 04054462913633 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462913732 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462913763 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462913794 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462913824 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462913831 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462913855 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462913893 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914005 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914012 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914036 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914067 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914074 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914081 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914098 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914104 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914111 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914142 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914203 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914234 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914241 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914258 evonos evonos GmbH & Co. KG LRC 2026-08-25
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