Home GUDID 00688346002263 Fine Osteotomy system - Proximal tibia
Primary DI 00688346002263
Brand Fine Osteotomy system - Proximal tibia
Company Laboratoires Bodycad Inc
Model 015-410-002
Catalog number 015-410-002
Device description Tibial plate, Cortical Locking Screws, cancellous Compression Screws and disposable instrumentation
Published 2021-11-29
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name HRS Plate, Fixation, Bone HWC Screw, Fixation, Bone PBF Orthopaedic Surgical Planning And Instrument Guides
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HRS Plate, Fixation, Bone Orthopedic 2 HWC Screw, Fixation, Bone Orthopedic 2 PBF Orthopaedic Surgical Planning And Instrument Guides Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00688346002263 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 00688346002263 00688346002263 688346002263 0688346002263
GMDN Terms# Term, Definition table Term Definition Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile A non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 202981171 Device count 1 Serial number true Manufacturing date on label true Expiration date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00688346000115 Fine Osteotomy disposable instruments - Distal femur 015-330-601 015-330-601 2020-05-20 00688346000139 Fine Osteotomy disposable instruments - Proximal tibia 015-410-601 015-410-601 2020-05-20 00688346000528 Fine Osteotomy disposable instruments - Distal femur 015-330-602 015-330-602 2020-05-20 00688346000535 Fine Osteotomy disposable instruments - Distal femur 015-330-603 015-330-603 2020-05-20 00688346000542 Fine Osteotomy disposable instruments - Proximal tibia 015-410-602 015-410-602 2020-05-20 00688346000559 Fine Osteotomy disposable instruments - Proximal tibia 015-410-603 015-410-603 2020-05-20 00688346003918 Fine TTO 014-340-001 2026-08-03 00688346005356 Fine Osteotomy System - Femoral plate 015-330-004 2026-08-03 00688346005387 Fine Osteotomy System - Femoral plate 015-330-007 2026-08-03 00688346005523 Fine Osteotomy System - Tibial plate 015-410-004 2026-08-03 00688346005554 Fine Osteotomy System - Tibial plate 015-410-007 2026-08-03 00688346002485 Fine osteotomy HA 4.5 Cortical Bone Screw - L30mm 037-106-030 2023-10-20 00688346002492 Fine osteotomy HA 4.5 Cortical Bone Screw - L32mm 037-106-032 2023-10-20 00688346002508 Fine osteotomy HA 4.5 Cortical Bone Screw - L34mm 037-106-034 2023-10-20 00688346002515 Fine osteotomy HA 4.5 Cortical Bone Screw - L36mm 037-106-036 2023-10-20 00688346002522 Fine osteotomy HA 4.5 Cortical Bone Screw - L38mm 037-106-038 2023-10-20 00688346002539 Fine osteotomy HA 4.5 Cortical Bone Screw - L40mm 037-106-040 2023-10-20 00688346002546 Fine osteotomy HA 4.5 Cortical Bone Screw - L42mm 037-106-042 2023-10-20 00688346002553 Fine osteotomy HA 4.5 Cortical Bone Screw - L44mm 037-106-044 2023-10-20 00688346002560 Fine osteotomy HA 4.5 Cortical Bone Screw - L46mm 037-106-046 2023-10-20
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