Home GUDID B1623161 DEMATOSCOPE WITH PROFESSIONAL SW (10X-90x)
Primary DI B1623161
Brand DEMATOSCOPE WITH PROFESSIONAL SW (10X-90x)
Company BELLEGROVE MEDICAL SUPPLY, INC.
Model BTS-316
Catalog number FEDMEDMICFIUVWPSWD_US
Device description DEMATOSCOPE WITH PROFESSIONAL SW (10X-90x)
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 B1623161 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 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# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 16972545090017 Jeashia Zhejiang Honsun Medical Technology Co., Ltd. ERA 2026-05-18 16972545090031 Jeashia Zhejiang Honsun Medical Technology Co., Ltd. ERA 2026-05-18 00050428029497 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED ERA 2026-02-13 KTS0025716 K.T.Surgico K.T.SURGICO ERA 2024-07-24 00311917035000 Walgreens WALGREEN CO. ERA 2023-11-01 20884392954455 Safety 1st DOREL JUVENILE GROUP, INC. ERA 2023-10-15 10884389104514 Medline MEDLINE INDUSTRIES, INC. ERA 2023-01-21 10884389104521 Medline MEDLINE INDUSTRIES, INC. ERA 2023-01-21 17290018446154 Nonagon N9+ NONAGON LTD ERA 2022-09-28 27290018446151 Nonagon N9+ SmartExam NONAGON LTD ERA 2022-09-28 M368122711 LABTRON GF HEALTH PRODUCTS, INC. ERA 2020-09-15 H65811255271 Henry Schein HENRY SCHEIN, INC. ERA 2020-06-16 H65811255281 Henry Schein HENRY SCHEIN, INC. ERA 2020-06-16 10304040029203 Henry Schein HENRY SCHEIN, INC. ERA 2018-12-21 10304040029197 Henry Schein HENRY SCHEIN, INC. ERA 2018-09-24 10381780403234 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION ERA 2018-08-16 10381780403289 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION ERA 2018-08-16 10381780403869 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION ERA 2018-08-16 10381780479369 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION ERA 2018-08-16 00634782087753 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087760 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087777 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087784 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087791 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087807 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087814 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087821 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087838 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087845 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087852 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12