Home GUDID 04250337105138 TESSYS®
Primary DI 04250337105138
Brand TESSYS®
Company Joimax GmbH
Model TER352835
Catalog number TER352835
Device description TESSYS® Endoscopic Reamer
Published 2022-12-30
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name HTO REAMER
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTO Reamer Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04250337105138 Package GS1 5 In Commercial Distribution 04250337101215 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04250337105138 04250337105138 4250337105138 04250337101215 04250337101215 4250337101215
GMDN Terms# Term, Definition table Term Definition Bone-resection orthopaedic reamer, single-use An orthopaedic surgical instrument intended to resect bone (cut out part of the bone) and precisely shape a specific area of bone to accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); some types may, in addition, be designed to be used endoscopically to resect hypertrophic tissue [e.g., ligamentum flavum] to relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Regulatory Flags# DUNS number 344267187 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 04250337118022 Intracs® JINTST15 JINTST15 2022-12-30 04250337118039 Intracs® JINTST18 JINTST18 2022-12-30 04250337118046 Intracs® JINTST23 JINTST23 2022-12-30 04250337116530 Joimax® Intracs® EM System Integrated Navigation Tracking & Control System JINT01S 2021-11-12 04250337116547 Joimax® Intracs® EM Panel PC JINTPC1105 2021-11-12 04250337116554 Joimax® Intracs® EM Control Unit JINTCU1115 2021-11-12 04250337116561 Joimax® Intracs® EM Field Generator JINTFG1125 2021-11-12 04250337116585 Joimax® Intracs® EM Patient Tracker JINTPT2235 2021-11-12 04250337116592 Joimax® Intracs® EM Sensor Clip JINTSC2205 2021-11-12 04250337116608 Joimax® Intracs® EM Sensor Wire 150 JINTSW2215 2021-11-12 04250337116615 Joimax® Intracs® EM Sensor Wire 180 JINTSW2218 2021-11-12 04250337116622 Joimax® Intracs® EM Sensor Wire 230 JINTSW2223 2021-11-12 04250337116646 Joimax® Intracs® EM Mounting Arm f field Generator mounting arm + rail clamp JINTMA1135 2021-11-12 04250337117667 Joimax® Intracs® EM Mounting Arm f. Patient Mapper mounting arm + rail clamp JINTMAP1136 2021-11-12 04250337117988 Wire cutter JINTWC 2021-11-12 04250337117995 Joimax® Intracs® EM Y-Adapter JINTYA35 2021-11-12 04250337118008 Joimax® Intracs® EM K-Wire Drill Guide W 18 mm x D 28 mm x H 60 mm JINTDG182860 2021-11-12 04250337118015 K-Wire w/ thread, Trocar w. 15 mm thread, round 1.5 mm x 150 mm JKW1515 2021-11-12 04250337118213 Joimax® Intracs® EM Patient Mapper - AP JINTPM2245-AP 2021-11-12 04250337118220 Joimax® Intracs® EM Patient Mapper - LAT JINTPM2245-LAT 2021-11-12
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840096408690 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408706 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408713 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408720 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408737 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408744 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408751 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408768 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408775 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408782 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408799 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408805 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408812 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408829 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408836 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408843 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408850 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408867 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408874 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408881 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408898 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408904 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408911 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408928 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408935 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408942 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408959 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408966 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408973 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408980 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03
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