Home GUDID 00643169984691 Medtronic Resuable Instruments
Primary DI 00643169984691
Brand Medtronic Resuable Instruments
Company MEDTRONIC SOFAMOR DANEK, INC.
Model EX0117046
Device description TUBE EX0117046 OUTER ASSY 4.75MM
Published 2022-09-09
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name HTC PLIERS, SURGICAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTC Pliers, Surgical General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00643169984691 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 00643169984691 00643169984691 643169984691 0643169984691
GMDN Terms# Term, Definition table Term Definition Orthopaedic rod reducer A heavy-duty, hand-held manual surgical instrument intended to be used to reduce or seat an implantable rod into the saddle of an implant (i.e., bone screw, spinal hook) used as a component of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. When the rod lies medial or lateral to the implant channel this instrument allows for controlled translation of the rod into the saddle of the screws and/or hooks. The surgeon is able to control the positioning (bending) of the rod into the saddle. Once the rod is securely seated in the saddle it is locked into position with a plug or a setscrew. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 830350380 Device count 1 DM exempt true Premarket exempt true Lot or batch 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 B8034802690 ORTHOMED ORTHO-MED, INC. HTC 2026-04-16 B8034803700 ORTHOMED ORTHO-MED, INC. HTC 2026-04-16 B8034803720 ORTHOMED ORTHO-MED, INC. HTC 2026-04-16 B8034709310 ORTHOMED ORTHO-MED, INC. HTC 2026-03-30 00840105223818 ZOLL DENTAL Zoll-Dental HTC 2025-09-16 00840105223825 ZOLL DENTAL Zoll-Dental HTC 2025-09-16 00840105223832 ZOLL DENTAL Zoll-Dental HTC 2025-09-16 10887587077628 NA Synthes GmbH HTC 2024-08-21 B356KJ666140 American Medicals American Medicals HTC 2024-07-11 10840199539458 Forcep KOROS U.S.A., INC. HTC 2024-02-01 10840199539489 Forcep KOROS U.S.A., INC. HTC 2024-02-01 10840199535900 Clamp KOROS U.S.A., INC. HTC 2024-01-31 10840199535962 C Clamp KOROS U.S.A., INC. HTC 2024-01-31 10840199535993 Aortic Clamp KOROS U.S.A., INC. HTC 2024-01-31 10840199536006 Aortic Clamp KOROS U.S.A., INC. HTC 2024-01-31 00841435121621 Tecomet TECOMET INC. HTC 2023-07-20 B356KJ526120 American Medicals American Medicals HTC 2022-12-14 14026704799135 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 14026704799142 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 14026704799159 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 14026704799166 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 14026704799319 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 14026704799326 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 14026704811448 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 10840199539830 Forceps KOROS U.S.A., INC. HTC 2022-10-31 10840199539847 Forceps KOROS U.S.A., INC. HTC 2022-10-31 10840199539854 Forceps KOROS U.S.A., INC. HTC 2022-10-31 10840199539861 Forceps KOROS U.S.A., INC. HTC 2022-10-31 10840199539878 Forceps KOROS U.S.A., INC. HTC 2022-10-31 10840199539885 Forceps KOROS U.S.A., INC. HTC 2022-10-31
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