Home GUDID 00763000395537 Medtronic Reusable Instruments
Primary DI 00763000395537
Brand Medtronic Reusable Instruments
Company MEDTRONIC SOFAMOR DANEK, INC.
Model EX0420065
Device description GUIDE EX0420065 DTS ASSEMBLY
Published 2022-10-13
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 FZS CURETTE, SURGICAL, GENERAL USE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FZS Curette, Surgical, General Use General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00763000395537 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 00763000395537 00763000395537 763000395537 0763000395537
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 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 B382SD9147092060 Surgical Direct Surgical Direct, Inc. FZS 2026-07-09 B382SD9147092120 Surgical Direct Surgical Direct, Inc. FZS 2026-07-09 B382SD9147092130 Surgical Direct Surgical Direct, Inc. FZS 2026-07-09 B382SD9147092140 Surgical Direct Surgical Direct, Inc. FZS 2026-07-09 B382SD9147096450 Surgical Direct Surgical Direct, Inc. FZS 2026-07-09 B382SD9147096460 Surgical Direct Surgical Direct, Inc. FZS 2026-07-09 B382SD9147096470 Surgical Direct Surgical Direct, Inc. FZS 2026-07-09 B382SD9147096510 Surgical Direct Surgical Direct, Inc. FZS 2026-07-09 B382SD9147096520 Surgical Direct Surgical Direct, Inc. FZS 2026-07-09 B382SD9147096530 Surgical Direct Surgical Direct, Inc. FZS 2026-07-09 B382SD9147096540 Surgical Direct Surgical Direct, Inc. FZS 2026-07-09 B382SD9147096550 Surgical Direct Surgical Direct, Inc. FZS 2026-07-09 07640139342119 ROMEO 2 INSTRUMENTATION SpineArt SA FZS 2025-11-10 04046963939588 NOVOCART Aesculap AG FZS 2020-04-24 04046963315511 NOVOCART Aesculap AG FZS 2020-04-23 04046963315528 NOVOCART Aesculap AG FZS 2020-04-23 10649111094002 Sklar SKLAR CORPORATION FZS 2019-08-26 10649111094088 Sklar SKLAR CORPORATION FZS 2019-08-26 10649111217210 Sklar SKLAR CORPORATION FZS 2019-03-15 10649111217494 Sklar SKLAR CORPORATION FZS 2019-03-15 10649111217586 Sklar SKLAR CORPORATION FZS 2019-03-15 10649111217838 Sklar SKLAR CORPORATION FZS 2019-03-15 10649111017711 Sklar SKLAR CORPORATION FZS 2019-03-13 10649111017858 Sklar SKLAR CORPORATION FZS 2019-03-13 10649111018084 Sklar SKLAR CORPORATION FZS 2019-03-13 10649111018282 Sklar SKLAR CORPORATION FZS 2019-03-13 10649111018619 Sklar SKLAR CORPORATION FZS 2019-03-13 10649111161612 Sklar SKLAR CORPORATION FZS 2019-03-13 10649111161964 Sklar SKLAR CORPORATION FZS 2019-03-13 10649111162060 Sklar SKLAR CORPORATION FZS 2019-03-13
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