Home GUDID 08800038044944 MEDINAUT Flex
Primary DI 08800038044944
Brand MEDINAUT Flex
Company IMEDICOM CO., LTD.
Model MDF1
Published 2020-10-16
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name OCJ Spinal Channeling Instrument, Vertebroplasty
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OCJ Spinal Channeling Instrument, Vertebroplasty Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08800038044944 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800038044944 08800038044944 8800038044944
GMDN Terms# Term, Definition table Term Definition Orthopaedic cement preparation/delivery kit A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.
Regulatory Flags# DUNS number 690340653 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08031497003689 Mendec® Kypho Set Monolateral 10 mm TECRES SPA OCJ 2025-12-17 08031497003696 Mendec® Kypho Set Monolateral 15 mm TECRES SPA OCJ 2025-12-17 08031497003702 Mendec® Kypho Set Monolateral 20 mm TECRES SPA OCJ 2025-12-17 08031497003801 Mendec® Kypho Set Bilateral 10 mm TECRES SPA OCJ 2025-12-17 08031497003818 Mendec® Kypho Set Bilateral 15 mm TECRES SPA OCJ 2025-12-17 08031497003825 Mendec® Kypho Set Bilateral 20 mm TECRES SPA OCJ 2025-12-17 08033860046613 BIOPSYBELL BIOPSYBELL SRL OCJ 2025-10-27 06923558507569 Kyphoplasty Tool Kit Jiangsu Changmei Medtech Co., Ltd. OCJ 2025-10-23 06923558509693 Kyphoplasty Tool Kit Jiangsu Changmei Medtech Co., Ltd. OCJ 2025-10-23 08809281659806 TVP System (Vertebra Plasty SET B) Taeyeon Medical co.,Ltd. OCJ 2025-09-03 08809281659417 PCD System Taeyeon Medical co.,Ltd. OCJ 2025-08-22 00815212026973 BLAZER-C CURVED INJECTION SYSTEM-MV Izi Medical Products, LLC OCJ 2025-05-21 B90829211908 Main-AXS Needle-Retropsoas Mainstream Medical Devices, LLC OCJ 2025-04-30 08053175016125 Vertebroplasty Needle ADRIA SRL OCJ 2025-04-07 B908350008000 Main-AXS Needle-Spinal Simplicity Mainstream Medical Devices, LLC OCJ 2024-12-03 B908350009000 Main-AXS Needle-Spinal Simplicity Mainstream Medical Devices, LLC OCJ 2024-12-03 08800046100380 CAPO Needle NEXONE BIO CO., LTD. OCJ 2024-10-29 08800046101080 CAPO Needle NEXONE BIO CO., LTD. OCJ 2024-10-29 08800046101202 CAPO Needle NEXONE BIO CO., LTD. OCJ 2024-10-29 08058964724687 V-Access G21 SRL OCJ 2024-10-16 08058964725356 V-Access G21 SRL OCJ 2024-10-16 08058964725363 V-Access G21 SRL OCJ 2024-10-16 08058964725417 V-Access G21 SRL OCJ 2024-10-16 08058964724021 KeyFix Direct Access Needle G21 SRL OCJ 2024-10-10 08058964724052 KeyFix Bone Cement Filler Cannula G21 SRL OCJ 2024-10-10 08058964724083 KeyFix Bone Cement Filler Cannula G21 SRL OCJ 2024-10-10 08058964724113 KeyFix Direct Access Needle G21 SRL OCJ 2024-10-10 08058964725431 V-Access G21 SRL OCJ 2024-10-10 08058964725448 V-Access G21 SRL OCJ 2024-10-10 08058964727725 Keyfix direct access needle 8G G21 SRL OCJ 2024-10-10