Home GUDID 09309000394319 MAC Surgical
Primary DI 09309000394319
Brand MAC Surgical
Company MAC SURGICAL PTY LTD
Model M01-457-500
Device description MAC Surgical OCT AA Cup Impactor - Zimmer G7 Cup compatible
Published 2025-12-01
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name HWA Impactor
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HWA Impactor Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 09309000394319 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 09309000394319 09309000394319 9309000394319
GMDN Terms# Term, Definition table Term Definition Orthopaedic implant impactor, reusable A metal and/or plastic hand-held manual surgical instrument designed to position an orthopaedic implant within the body by transmission of an impact force that drives the implant into its final position. The proximal end of the instrument is a handle usually designed to absorb the impact from a surgical hammer or mallet, and the distal end is usually shaped to conform to the implant shape (flat or anatomically curved) or is shaped like a chisel handle to facilitate implant positioning. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 752688838 Device count 1 DM exempt true Premarket exempt true Kit true Lot or batch true Manufacturing date on label 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 10603295543718 ATTUNE DEPUY (IRELAND) HWA 2025-10-31 10603295543725 ATTUNE DEPUY (IRELAND) HWA 2025-10-31 07613327538601 INSTRUMENT Howmedica Osteonics Corp. HWA 2023-06-30 10603295549581 INHANCE DEPUY (IRELAND) HWA 2023-02-28 10603295539346 INHANCE DEPUY (IRELAND) HWA 2021-08-30 07640178983052 JULIET ® INSTRUMENTATION SpineArt SA HWA 2019-02-01 10705034717364 NA Synthes GmbH HWA 2019-01-18 10603295423324 ATTUNE DEPUY (IRELAND) HWA 2018-09-24 M684201620111 MICROPORT Microport Orthopedics Inc. HWA 2018-09-13 10705034720883 NA SYNTHES (U.S.A.) LP HWA 2018-08-17 10381780408451 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HWA 2018-08-16 10381780479406 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HWA 2018-08-16 10381780266389 Integra™Allograft Wedge System Ascension Orthopedics, Inc. HWA 2018-04-13 10381780282457 Integra® PyroCarbon Ascension Orthopedics, Inc. HWA 2018-04-13 10381780279495 K2™ Hemi Toe Implant System Ascension Orthopedics, Inc. HWA 2018-04-10 10381780279907 KGTI™ Kinetik Great Toe Implant System Ascension Orthopedics, Inc. HWA 2018-04-10 10381780224815 Integra® Ruggles®-Redmond™ INTEGRA LIFESCIENCES PRODUCTION CORPORATION HWA 2018-03-23 10381780224822 Integra® Ruggles®-Redmond™ INTEGRA LIFESCIENCES PRODUCTION CORPORATION HWA 2018-03-23 10381780224839 Integra® Ruggles®-Redmond™ INTEGRA LIFESCIENCES PRODUCTION CORPORATION HWA 2018-03-23 10381780224846 Integra® Ruggles®-Redmond™ INTEGRA LIFESCIENCES PRODUCTION CORPORATION HWA 2018-03-23 10381780224853 Integra® Ruggles®-Redmond™ INTEGRA LIFESCIENCES PRODUCTION CORPORATION HWA 2018-03-23 10381780224860 Integra® Ruggles®-Redmond™ INTEGRA LIFESCIENCES PRODUCTION CORPORATION HWA 2018-03-23 10381780224877 Integra® Ruggles®-Redmond™ INTEGRA LIFESCIENCES PRODUCTION CORPORATION HWA 2018-03-23 10381780224884 Integra® Ruggles®-Redmond™ INTEGRA LIFESCIENCES PRODUCTION CORPORATION HWA 2018-03-23 10381780224891 Integra® Ruggles®-Redmond™ INTEGRA LIFESCIENCES PRODUCTION CORPORATION HWA 2018-03-23 10381780278283 Integra® Freedom Wrist Arthroplasty System Ascension Orthopedics, Inc. HWA 2018-03-09 10381780278290 Integra® Freedom Wrist Arthroplasty System Ascension Orthopedics, Inc. HWA 2018-03-09 10381780278641 Integra® Freedom Wrist Arthroplasty System Ascension Orthopedics, Inc. HWA 2018-03-09 10381780278863 Universal 2™ Total Wrist Implant System Ascension Orthopedics, Inc. HWA 2018-03-09 10381780278870 Universal 2™ Total Wrist Implant System Ascension Orthopedics, Inc. HWA 2018-03-09
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