Home GUDID 00859810006241 OBALON®
Primary DI 00859810006241
Brand OBALON®
Company Medtimo, Inc
Model 7405-0001
Device description OBALON® Recalibration Tool - component for use with the OBALON® Navigation Console
Published 2019-02-20
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Unsafe
Rx true Product Codes# Code, Name table Code Name LTI Implant, Intragastric For Morbid Obesity
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LTI Implant, Intragastric For Morbid Obesity Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00859810006241 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00859810006241 00859810006241 859810006241 0859810006241
GMDN Terms# Term, Definition table Term Definition Gastrointestinal catheter/endoscope tracking system A multicomponent assembly of mains electricity (AC-powered) devices designed for real-time visualization/navigation of a catheter and/or endoscope during insertion in the gastrointestinal tract, by detecting its position/movement within an electromagnetic (EM) field and displaying three-dimensional (3-D) virtual images on a monitoring screen. The system primarily consists of a main control unit with monitor and an external EM field generator or sensor, and may also require/include an external reference sensor; additional accessories (e.g., remote control, stand/trolley) may also be included.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep dry Special Storage Condition, Specify 0 0 Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing Storage Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Storage Environment Temperature 14 Degrees Fahrenheit 104 Degrees Fahrenheit
Regulatory Flags# DUNS number 144843751 Device count 1 Lot or batch true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850007764470 ReShape Calibration Tubes™ B-2017 B-2017 2025-08-01 00850007764258 ReShape Calibration Tubes B-2032 B-2032 2023-03-16 00850007764265 ReShape Calibration Tubes B-2036 B-2036 2023-03-16 00850007764272 ReShape Calibration Tubes B-2040 B-2040 2023-03-16 00850007764203 Gastric Balloon Suction Catheter B-2020 B-2020 2020-11-01 00859810006005 OBALON® Placebo Capsule 7150-0003 2016-12-12 00859810006012 OBALON® EzFill™ Can 8200-0001 2016-12-22 00859810006050 OBALON® Balloon System 9500-0001 2016-12-26 00859810006081 OBALON® Placebo Capsule HPMC 7650-0002 2017-07-11 00859810006210 OBALON® Inflation Can 8200-0001 2018-07-11 00859810006227 OBALON® 9410-0001 2019-02-20 00859810006265 Obalon Aspiration Adapter 6100-0004 2018-08-09 00850007764500 ReShape Lap-Band® 2.0 FLEX, Standard D-3360 D-3360 2024-01-22 00850007764517 ReShape Lap-Band® 2.0 FLEX, Large D-3365 D-3365 2024-01-22 00850007764548 ReShape Lap-Band® 2.0, FLEX & Access Port, Standard D-3304 D-3304 2024-01-22 00850007764555 ReShape Lap-Band® 2.0, FLEX & Access Port, Large D-3306 D-3306 2024-01-22 00850007764586 ReShape Lap-Band® 2.0, FLEX Tubing Kit D-3500 D-3500 2024-01-22 10850007764323 LAP-BAND® System Access Port Needle, 20G x 51 mm (2 in.) B-20302-10 B-20302-10 2021-04-01 10850007764330 LAP-BAND® System Access Port Needle, 20G x 89 mm (3.5 in.) B-20301-10 B-20301-10 2021-04-01 00850007764043 RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System Standard C-2304 C-2304 2021-02-01
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00191506049232 Orbera™ BOSTON SCIENTIFIC CORPORATION LTI 2026-06-04 00810010540119 Allurion™ Gastric Balloon System Allurion Technologies, Inc. LTI 2026-04-07 00810010540126 Allurion™ Filler Kit Allurion Technologies, Inc. LTI 2026-04-07 00810010540133 Allurion™ Stylet Allurion Technologies, Inc. LTI 2026-04-07 03665039001663 Endoline PUNC PRINCE MEDICAL LTI 2024-01-30 03665039005630 Extraction Kit PRINCE MEDICAL LTI 2024-01-30 00850007764500 ReShape Lap-Band® 2.0 FLEX, Standard Medtimo, Inc LTI 2024-01-22 00850007764517 ReShape Lap-Band® 2.0 FLEX, Large Medtimo, Inc LTI 2024-01-22 00850007764548 ReShape Lap-Band® 2.0, FLEX & Access Port, Standard Medtimo, Inc LTI 2024-01-22 00850007764555 ReShape Lap-Band® 2.0, FLEX & Access Port, Large Medtimo, Inc LTI 2024-01-22 00850007764586 ReShape Lap-Band® 2.0, FLEX Tubing Kit Medtimo, Inc LTI 2024-01-22 00860005178803 Spatz3 Adjustable Balloon System insertion kit SPATZ FGIA (ISRAEL) LTD LTI 2021-10-20 10850007764323 LAP-BAND® System Access Port Needle, 20G x 51 mm (2 in.) Medtimo, Inc LTI 2021-04-01 10850007764330 LAP-BAND® System Access Port Needle, 20G x 89 mm (3.5 in.) Medtimo, Inc LTI 2021-04-01 00850007764043 RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System Standard Medtimo, Inc LTI 2021-02-01 00850007764067 RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System Large Medtimo, Inc LTI 2021-02-01 00850007764609 LAP-BAND® AP System Standard with RapidPort® EZ Medtimo, Inc LTI 2021-02-01 00850007764654 LAP-BAND® AP System Large with RapidPort® EZ Medtimo, Inc LTI 2021-02-01 00850007764906 RapidPort® EZ Port Applier Medtimo, Inc LTI 2021-01-01 00850007764173 LAP-BAND® System Calibration Tube ReShape Lifesciences Inc. LTI 2020-12-01 00859810006227 OBALON® Medtimo, Inc LTI 2019-02-20 00859810006104 OBALON Touch™ Medtimo, Inc LTI 2019-02-20 00859810006142 OBALON® Medtimo, Inc LTI 2019-02-20 00859810006173 OBALON® Medtimo, Inc LTI 2019-02-20 00859810006180 OBALON® Medtimo, Inc LTI 2019-02-20 00859810006197 OBALON® Medtimo, Inc LTI 2019-02-20 00859810006203 OBALON Touch™ Medtimo, Inc LTI 2019-02-20 10859810006224 OBALON® OBALON THERAPEUTICS, INC. LTI 2019-02-20 00859810006234 OBALON® Medtimo, Inc LTI 2019-02-20 00859810006210 OBALON® Inflation Can Medtimo, Inc LTI 2018-07-11
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