Home GUDID H981324070 NA
Primary DI H981324070
Brand NA
Company Synthes GmbH
Model 324.07
Catalog number 32407
Device description SCREWDRIVER SHAFT FOR EXPANSIONHEAD SCREWS
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 FSM TRAY, SURGICAL, INSTRUMENT
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FSM Tray, Surgical, Instrument General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10705034769219 Primary GS1 0 H981324070 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10705034769219 10705034769219
GMDN Terms# Term, Definition table Term Definition Surgical screwdriver, reusable A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 486711679 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 10889950157562 Hu-Friedy HU-FRIEDY MFG. CO., LLC FSM 2026-07-13 10889950157579 Hu-Friedy HU-FRIEDY MFG. CO., LLC FSM 2026-07-13 00889929072400 NEXXT MATRIXX® SI System NEXXT SPINE, LLC FSM 2026-07-10 07640177821393 Neo Medical Pedicle screw kit Neo Medical SA FSM 2026-07-10 07640177821409 Neo Medical Pedicle screw kit Neo Medical SA FSM 2026-07-10 07640177821416 Neo Medical Pedicle screw kit Neo Medical SA FSM 2026-07-10 G079IVA22025000 Golden Isles Pedicle Screw System Intelivation, LLC FSM 2026-07-10 G079IVA22026000 Golden Isles Pedicle Screw System Intelivation, LLC FSM 2026-07-10 00840286860086 Consensus Knee System Shalby Advanced Technologies, Inc. FSM 2026-07-09 M697X07900081 Silex Sacroiliac Joint Fusion System Xtant Medical Holdings, Inc. FSM 2026-07-08 00840456220283 JMU JMU DENTAL, INC FSM 2026-07-07 00190446907466 EF1 Medshape, Inc. FSM 2026-06-25 00190446907473 EF1 Medshape, Inc. FSM 2026-06-25 00190776421724 Millennium Avalign Technologies, Inc. FSM 2026-06-24 00885556924730 EVOS Smith & Nephew, Inc. FSM 2026-06-24 00840456200308 JMU JMU DENTAL, INC FSM 2026-06-23 00840456200315 JMU JMU DENTAL, INC FSM 2026-06-23 00840456201176 JMU JMU DENTAL, INC FSM 2026-06-23 00840456201206 JMU JMU DENTAL, INC FSM 2026-06-23 00840456201213 JMU JMU DENTAL, INC FSM 2026-06-23 00840456201220 JMU JMU DENTAL, INC FSM 2026-06-23 00840456201237 JMU JMU DENTAL, INC FSM 2026-06-23 00840456201244 JMU JMU DENTAL, INC FSM 2026-06-23 00840456201251 JMU JMU DENTAL, INC FSM 2026-06-23 00840456201268 JMU JMU DENTAL, INC FSM 2026-06-23 00840456206706 JMU JMU DENTAL, INC FSM 2026-06-23 00840456206713 JMU JMU DENTAL, INC FSM 2026-06-23 00840456207000 JMU JMU DENTAL, INC FSM 2026-06-23 00840456214077 JMU JMU DENTAL, INC FSM 2026-06-23 00840456214084 JMU JMU DENTAL, INC FSM 2026-06-23
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