Home GUDID 08698940936095 Sayan
Primary DI 08698940936095
Brand Sayan
Company SAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETI
Model 1040.57.003
Catalog number 1040.57.003
Device description Acetabular Reamer Hex Coupling Ø42
Published 2024-12-24
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 LXH Orthopedic Manual Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08698940936095 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08698940936095 08698940936095 8698940936095
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 566214005 Device count 1 Premarket exempt 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 00840286860093 Tahoe Unicompartmental Knee System Shalby Advanced Technologies, Inc. LXH 2026-07-09 00840286860109 Tahoe Unicompartmental Knee System Shalby Advanced Technologies, Inc. LXH 2026-07-09 00840286860116 Tahoe Unicompartmental Knee System Shalby Advanced Technologies, Inc. LXH 2026-07-09 10705034647463 N/A Medos International Sàrl LXH 2026-07-09 B382SD49400B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49401B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49402B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49403B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49404B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49405B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49406B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49407B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49408B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49409B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49410B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49411B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49412B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49413B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49414B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49415B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49416B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49417B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49418B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49419B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49420B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD500010 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD500020 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD500030 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD500040 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD500050 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09
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