Home GUDID H981SD3240640 NA
Primary DI H981SD3240640
Brand NA
Company SYNTHES (U.S.A.) LP
Model SD324.064
Catalog number SD324064
Device description PEDICLE MARKER INSERTION/ REMOVAL INSTRUMENT
Published 2016-12-31
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name HXB PROBE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HXB Probe Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10705034705958 Primary GS1 0 H981SD3240640 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10705034705958 10705034705958
GMDN Terms# Term, Definition table Term Definition Orthopaedic implant inserter/extractor, reusable A hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 832637081 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 false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 05060267134554 FORCECORD Passing Probe XIROS LTD HXB 2026-07-06 06974940307830 endophix Suzhou Endophix Co., Ltd. HXB 2026-06-23 04052536218073 uCentum Ulrich GmbH & Co. KG HXB 2026-06-09 04052536218080 uCentum Ulrich GmbH & Co. KG HXB 2026-06-09 00199150080304 Medtronic Reusable Instruments MEDTRONIC SOFAMOR DANEK, INC. HXB 2026-06-05 00846338005474 Probe ELLIQUENCE, LLC HXB 2026-06-01 04052536085507 neon3 Ulrich GmbH & Co. KG HXB 2026-05-28 07640221373045 PERLA ® TL SpineArt SA HXB 2026-05-07 08800322758151 Anyplus ll Spinal Fixation System GS Medical Co., Ltd. HXB 2026-04-21 08800322758168 Anyplus ll Spinal Fixation System GS Medical Co., Ltd. HXB 2026-04-21 08800017271095 Probe Corentec Co., Ltd HXB 2026-04-10 10649111181665 Sklar Instruments SKLAR CORPORATION HXB 2025-05-29 08809885720001 Anyplus II Spinal Fixation System GS Medical Co., Ltd. HXB 2025-03-17 08809885720018 Anyplus II Spinal Fixation System GS Medical Co., Ltd. HXB 2025-03-17 07640177820631 Neo Medical Pedicle Screw System Neo Medical SA HXB 2023-01-26 07898506815241 Quinelato Schobell Industrial Ltda HXB 2023-01-09 07899798204461 Schobell Schobell Industrial Ltda HXB 2022-12-16 G079C5020010040 Golden Isles Pedicle Screw System Intelivation, LLC HXB 2022-10-26 10649111296673 Sklar SKLAR CORPORATION HXB 2019-03-19 10649111296932 Sklar SKLAR CORPORATION HXB 2019-03-19 10649111297120 Sklar SKLAR CORPORATION HXB 2019-03-19 10649111297496 Sklar SKLAR CORPORATION HXB 2019-03-19 10649111376351 Sklar® SKLAR CORPORATION HXB 2019-02-25 10649111376474 Sklar® SKLAR CORPORATION HXB 2019-02-25 10649111377655 Sklar® SKLAR CORPORATION HXB 2019-02-25 10649111377785 Sklar® SKLAR CORPORATION HXB 2019-02-25 10649111255212 Sklar® SKLAR CORPORATION HXB 2019-02-14 10649111255342 Sklar® SKLAR CORPORATION HXB 2019-02-14 10649111255502 Sklar® SKLAR CORPORATION HXB 2019-02-14 10649111255649 Sklar® SKLAR CORPORATION HXB 2019-02-14
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