Home GUDID 04046963891992 COLUMBUS REVISION
Primary DI 04046963891992
Brand COLUMBUS REVISION
Company Aesculap AG
Model NQ794R
Catalog number NQ794R
Device description COLUMBUS REV FEMUR BOX CHISEL
Published 2020-05-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name KDG CHISEL (OSTEOTOME)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KDG Chisel (Osteotome) General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04046963891992 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04046963891992 04046963891992 4046963891992
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation positioning instrument, reusable A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 315018218 Device count 1 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 B382SD918006150 Surgical Direct Surgical Direct, Inc. KDG 2026-07-13 B382SD918006200 Surgical Direct Surgical Direct, Inc. KDG 2026-07-13 B382SD921381110 Surgical Direct Surgical Direct, Inc. KDG 2026-02-12 B382SD9144841130 Surgical Direct Surgical Direct, Inc. KDG 2025-11-05 B382SD9144841180 Surgical Direct Surgical Direct, Inc. KDG 2025-11-05 B382SD9144841190 Surgical Direct Surgical Direct, Inc. KDG 2025-11-05 B382SD921613120 Surgical Direct Surgical Direct, Inc. KDG 2025-11-05 B382SD9233201100 Surgical Direct Surgical Direct, Inc. KDG 2025-11-05 B382SD9233201110 Surgical Direct Surgical Direct, Inc. KDG 2025-11-05 00198506086465 ELMED INCORPORATED ELMED INCORPORATED KDG 2025-11-05 B382SD62622020 Surgical Direct Surgical Direct, Inc. KDG 2025-10-14 B382SD62622040 Surgical Direct Surgical Direct, Inc. KDG 2025-10-14 B382SD62622060 Surgical Direct Surgical Direct, Inc. KDG 2025-10-14 B382SD62622070 Surgical Direct Surgical Direct, Inc. KDG 2025-10-14 B382SD62622080 Surgical Direct Surgical Direct, Inc. KDG 2025-10-14 B382SD62622090 Surgical Direct Surgical Direct, Inc. KDG 2025-10-14 B382SD62622100 Surgical Direct Surgical Direct, Inc. KDG 2025-10-14 B382SD62622120 Surgical Direct Surgical Direct, Inc. KDG 2025-10-14 10840199528834 Comfort Plus Chisel KOROS U.S.A., INC. KDG 2025-01-31 10888277381339 MEDLINE MEDLINE INDUSTRIES, INC. KDG 2025-01-29 10888277392304 MEDLINE MEDLINE INDUSTRIES, INC. KDG 2025-01-29 10840199511423 Chisel KOROS U.S.A., INC. KDG 2024-12-31 10840199511430 Chisel KOROS U.S.A., INC. KDG 2024-12-31 10840199527394 Osteotome KOROS U.S.A., INC. KDG 2024-12-31 10840199527400 Osteotome KOROS U.S.A., INC. KDG 2024-12-31 10840199527417 Osteotome KOROS U.S.A., INC. KDG 2024-12-31 10840199527424 Osteotome KOROS U.S.A., INC. KDG 2024-12-31 10840199527431 Osteotome KOROS U.S.A., INC. KDG 2024-12-31 10840199527448 Osteotome KOROS U.S.A., INC. KDG 2024-12-31 10840199527455 Osteotome KOROS U.S.A., INC. KDG 2024-12-31
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