Home GUDID H981SD036179620 Zero-P
Primary DI H981SD036179620
Brand Zero-P
Company SYNTHES (U.S.A.) LP
Model SD03.617.962
Catalog number SD03617962
Device description ANGLED DRILL GUIDE WITH HANDLE ZERO-P
Published 2015-09-14
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 OVE Intervertebral fusion device with integrated fixation, cervical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10705034701998 Primary GS1 0 H981SD036179620 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10705034701998 10705034701998
GMDN Terms# Term, Definition table Term Definition Surgical drill guide, reusable A manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. 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 false 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 00810216329235 ZSAlign Cervical Interbody System-Screw Zsfab, Inc. OVE 2026-10-14 00810216329242 ZSAlign Cervical Interbody System-Screw Zsfab, Inc. OVE 2026-10-14 00810216329259 ZSAlign Cervical Interbody System-Screw Zsfab, Inc. OVE 2026-10-14 00810216329266 ZSAlign Cervical Interbody System-Screw Zsfab, Inc. OVE 2026-10-14 00810216329273 ZSAlign Cervical Interbody System-Screw Zsfab, Inc. OVE 2026-10-14 00810216329280 ZSAlign Cervical Interbody System-Screw Zsfab, Inc. OVE 2026-10-14 00810216329297 ZSAlign Cervical Interbody System-Screw Zsfab, Inc. OVE 2026-10-14 00810216329303 ZSAlign Cervical Interbody System-Screw Zsfab, Inc. OVE 2026-10-14 00810216329310 ZSAlign Cervical Interbody System-Screw Zsfab, Inc. OVE 2026-10-14 00810216329334 ZSAlign Cervical Interbody System-Screw Zsfab, Inc. OVE 2026-10-14 00810216329341 ZSAlign Cervical Interbody System-Screw Zsfab, Inc. OVE 2026-10-14 00810216329358 ZSAlign Cervical Interbody System-Screw Zsfab, Inc. OVE 2026-10-14 00810216329372 ZSAlign Cervical Interbody System-Screw Zsfab, Inc. OVE 2026-10-14 00810216329389 ZSAlign Cervical Interbody System-Screw Zsfab, Inc. OVE 2026-10-14 00810216329396 ZSAlign Cervical Interbody System-Screw Zsfab, Inc. OVE 2026-10-14 00810216329402 ZSAlign Cervical Interbody System-Screw Zsfab, Inc. OVE 2026-10-14 00810216329419 ZSAlign Cervical Interbody System-Screw Zsfab, Inc. OVE 2026-10-14 00889981124390 Shoreline™ ACS Seaspine Orthopedics Corporation OVE 2019-07-26 00889981124406 Shoreline™ ACS Seaspine Orthopedics Corporation OVE 2019-07-26 00889981124413 Shoreline™ ACS Seaspine Orthopedics Corporation OVE 2019-07-26 00889981124420 Shoreline™ ACS Seaspine Orthopedics Corporation OVE 2019-07-26 00889981124437 Shoreline™ ACS Seaspine Orthopedics Corporation OVE 2019-07-26 00889981124444 Shoreline™ ACS Seaspine Orthopedics Corporation OVE 2019-07-26 00889981124451 Shoreline™ ACS Seaspine Orthopedics Corporation OVE 2019-07-26 00889981124468 Shoreline™ ACS Seaspine Orthopedics Corporation OVE 2019-07-26 00889981142301 Shoreline™ ACS Seaspine Orthopedics Corporation OVE 2019-07-26 00889981142318 Shoreline™ ACS Seaspine Orthopedics Corporation OVE 2019-07-26 00889981142325 Shoreline™ ACS Seaspine Orthopedics Corporation OVE 2019-07-26 00889981142332 Shoreline™ ACS Seaspine Orthopedics Corporation OVE 2019-07-26 00889981142349 Shoreline™ ACS Seaspine Orthopedics Corporation OVE 2019-07-26
xx.xx