Home GUDID B1623071 DENTALSCOPE
Primary DI B1623071
Brand DENTALSCOPE
Company BELLEGROVE MEDICAL SUPPLY, INC.
Model BTS-307
Catalog number FEDMEDMICFIDE_US
Device description DENTALSCOPE
Published 2021-09-27
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Safe
OTC true Product Codes# Code, Name table Code Name ERA Otoscope
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ERA Otoscope Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B1623071 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Otoscope, direct 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.
Regulatory Flags# DUNS number 141647094 Device count 1 Premarket exempt true Serial number true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published BTS702 B Travel Savvy Sharps Container BTS-702 BTS-702 2016-07-01 B1623111 IRISCOPE BTS-311 MICFIIRD5M_US 2021-09-27 B1621250 N.100 SPECULUM 7.0MM BTS-325 FEDMEDSP7,0_US 2021-10-12 B1623241 N.100 SPECULUM 6.0MM BTS-324 FEDMEDSP6,0_US 2021-10-12 B1623261 CONTACT CAP H=30MM CAMPATIBLE WITH FEDMEDMICFIP/5M BTS-326 MICFICL30_US 2021-10-12 B1623271 CLOSED CAP FOR FEDMEDMICFIP/P5M/UVW/UVWP/STD BTS-327 MICFICLOSEDCAP_US 2021-10-12 B1623211 N.100 SPECULUM 3.5MM BTS-321 FEDMEDSP3,5_US 2021-10-11 B1623221 N.100 SPECULUM 4.3MM BTS-322 FEDMEDSP4,3_US 2021-10-11 B1623231 N.100 SPECULUM 5.0MM BTS-323 FEDMEDSP5,0_US 2021-10-11 B1623001 DERMATOCOPE - POLARIZED FILTER BTS-300 FEDMEDMICFIP_US 2021-09-27 B1623021 DEMATOCOPE HIGH RESOLUTION BTS-302 FEDMEDMICFIP6M_US 2021-09-27 B1623061 OTOSCOPE BTS-306 FEDMEDMICFIOT_US 2021-09-27 B1623081 CAPILLAROSCOPE BTS-308 FEDMEDMICFIT6_US 2021-09-27 B1623091 WI-FI CAMERA FOR OPTICAL DEVICES BTS-309 FEDMEDMICFIEYE_US 2021-09-27 B1623101 DERMATOSCOPE / CAPILLAROSCOPE BTS-310 FEDMEDMICFISTD_US 2021-09-27 B1623121 IRISCOPE - HIGH RESOLUTION 5MP BTS-312 MICFIIRID5M_US 2021-09-27 B1623131 Dermatocope with polarized filter BTS-313 FEDMEDICFIUVWP_US 2021-09-27 B1623141 DEMATOSCOPE WITH PROFESSIONAL SW (5X-200x) BTS-314 FEDMEDMICFIPSWD_US 2021-09-27 B1623151 HIGH RESOLUTION DEMATOSCOPE WITH PROFESSIONAL SW BTS-315 FEDMEDMICFIP6MSWD_US 2021-09-27 B1623161 DEMATOSCOPE WITH PROFESSIONAL SW (10X-90x) BTS-316 FEDMEDMICFIUVWPSWD_US 2021-09-27
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