Home GUDID B1621031 WHITE LIGHT WI-FI DERMATOSCOPE
Primary DI B1621031
Brand WHITE LIGHT WI-FI DERMATOSCOPE
Company BELLEGROVE MEDICAL SUPPLY, INC.
Model BTS-302
Catalog number BTS-302
Published 2021-08-18
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
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 B1621031 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Video otoscope/audiometer An electrically-powered portable device intended for the visual examination of the outer ear canal/tympanic membrane by video otology, and basic evaluation of hearing function. It consists of a speculum with integrated video camera, light source, pitch generator (speaker), and a dedicated smartphone for image display and data relay to a central datastore; it may provide a conduit for a microsuction device.
Regulatory Flags# DUNS number 141647094 Device count 1 DM exempt true 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 B1623071 DENTALSCOPE BTS-307 FEDMEDMICFIDE_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
Other Devices Sharing Product Codes#