Home GUDID J021300030021 TG-98 LM Synea 400
Primary DI J021300030021
Brand TG-98 LM Synea 400
Company W & H Dentalwerk Bürmoos GmbH
Model 30003002
Device description Synea Highspeed Handpiece
Published 2018-08-31
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name FDA Enteroscope And Accessories
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FDA Enteroscope And Accessories Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status J021300030020 Direct Marking HIBCC 0 J021300030021 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Dental surgical power tool motorized handpiece/set, pneumatic A pneumatically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade] for drilling, cutting, polishing, and/or inserting procedures involving bones and tough tissues during a dental surgical procedure. It includes a pneumatic motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces, and typically includes a pneumatic hose; the endpieces are not included. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 300238441 Device count 1 Serial number true Manufacturing date on label true Contains natural rubber latex true 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 00860014745003 FUJIFILM Stiffening Wire (SW-2000) Fujifilm Healthcare Americas Corporation FDA 2025-12-18 04547410491715 FUJIFILM FUJIFILM CORPORATION FDA 2024-07-05 04547410514056 FUJIFILM FUJIFILM CORPORATION FDA 2024-07-05 14547410491712 FUJIFILM FUJIFILM CORPORATION FDA 2024-07-05 14547410514053 FUJIFILM FUJIFILM CORPORATION FDA 2024-07-05 10197106523643 CARDINAL HEALTH Cardinal Health 200, LLC FDA 2024-01-24 50197106523641 CARDINAL HEALTH Cardinal Health 200, LLC FDA 2024-01-24 10197106447185 CARDINAL HEALTH Cardinal Health 200, LLC FDA 2023-11-09 50197106447183 CARDINAL HEALTH Cardinal Health 200, LLC FDA 2023-11-09 10860006600805 Ancora Aspero Medical, Inc. FDA 2023-10-26 00847627004703 CD138 + Cyclin D1 BIOCARE MEDICAL LLC FDA 2023-06-21 04547410467284 FUJIFILM FUJIFILM CORPORATION FDA 2023-02-06 04547410324280 FUJIFILM FUJIFILM CORPORATION FDA 2023-02-06 04547410467260 FUJIFILM FUJIFILM CORPORATION FDA 2023-02-06 14547410467281 FUJIFILM FUJIFILM CORPORATION FDA 2023-02-06 04547410463439 FUJIFILM FUJIFILM CORPORATION FDA 2022-01-30 04953170165801 HANGER ADAPTER SET OLYMPUS MEDICAL SYSTEMS CORP. FDA 2021-12-17 04953170165825 PROBE ARM SET A OLYMPUS MEDICAL SYSTEMS CORP. FDA 2021-12-17 04953170165849 PROBE ARM SET B OLYMPUS MEDICAL SYSTEMS CORP. FDA 2021-12-17 04953170165740 STOPPER OLYMPUS MEDICAL SYSTEMS CORP. FDA 2021-12-16 04953170165757 WATER RESISTANT CAP OLYMPUS MEDICAL SYSTEMS CORP. FDA 2021-12-16 04953170165764 PROBE HANGER OLYMPUS MEDICAL SYSTEMS CORP. FDA 2021-12-16 06934955960246 Jade PTA Balloon Dilatation Catheter OrbusNeich Medical (ShenZhen) Co., Ltd. FDA 2020-12-25 00052569143735 HealthMart STRATEGIC SOURCING SERVICES LLC FDA 2020-07-31 10052569143732 HealthMart MCKESSON CORPORATION FDA 2020-07-31 00075289122811 ProWorks TRANZONIC COMPANIES, THE FDA 2020-04-02 70075289122810 ProWorks TRANZONIC COMPANIES, THE FDA 2020-04-02 04547410384536 FUJIFILM FUJIFILM CORPORATION FDA 2019-07-04 00811503033316 Q UROLOGICAL PERSISTENT AGUAMEDICINA Q UROLOGICAL CORPORATION FDA 2019-03-27 10811503033306 Q UROLOGICAL PERSISTENT AGUAMEDICINA Q UROLOGICAL CORPORATION FDA 2019-03-27