Home GUDID 08800038054332 MEDINAUT-V
Primary DI 08800038054332
Brand MEDINAUT-V
Company IMEDICOM CO., LTD.
Model 11G-100
Device description 100mm
Published 2023-08-31
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 OAR Injector, Vertebroplasty (Does Not Contain Cement)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OAR Injector, Vertebroplasty (Does Not Contain Cement) Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08800038054332 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800038054332 08800038054332 8800038054332
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 08058964729163 KeyFix_FILLER CANNULA FOR FENESTRATED SCREW 8-16 G G21 SRL OAR 2026-05-05 03701505801211 Dynamo TEKNIMED OAR 2026-02-02 03701505801228 Dynamo TEKNIMED OAR 2026-02-02 03701505801235 Dynamo TEKNIMED OAR 2026-02-02 08031497003689 Mendec® Kypho Set Monolateral 10 mm TECRES SPA OAR 2025-12-17 08031497003696 Mendec® Kypho Set Monolateral 15 mm TECRES SPA OAR 2025-12-17 08031497003702 Mendec® Kypho Set Monolateral 20 mm TECRES SPA OAR 2025-12-17 08031497003801 Mendec® Kypho Set Bilateral 10 mm TECRES SPA OAR 2025-12-17 08031497003818 Mendec® Kypho Set Bilateral 15 mm TECRES SPA OAR 2025-12-17 08031497003825 Mendec® Kypho Set Bilateral 20 mm TECRES SPA OAR 2025-12-17 06923558507569 Kyphoplasty Tool Kit Jiangsu Changmei Medtech Co., Ltd. OAR 2025-10-23 06923558509693 Kyphoplasty Tool Kit Jiangsu Changmei Medtech Co., Ltd. OAR 2025-10-23 08053175003439 Vertebroplasty Injector Kit ADRIA SRL OAR 2025-04-07 08053175004382 Cement Injection Cannula ADRIA SRL OAR 2025-04-07 03701505801020 PureKit Syringe 1.5cc MV TEKNIMED OAR 2025-03-31 03701505801037 META+ System 1.5cc MV TEKNIMED OAR 2025-03-31 03701505801075 PUREKIT Syringes TEKNIMED OAR 2025-03-31 03701505801082 Syringes 4cc TEKNIMED OAR 2025-03-31 03701505801099 Syringes 1.5cc TEKNIMED OAR 2025-03-31 03701505800498 PureKit Syringe 4cc MV TEKNIMED OAR 2025-03-31 00884450837542 StabiliT TOUCH™ Syringe Merit Medical Systems, Inc. OAR 2024-12-20 10884450837549 StabiliT TOUCH™ Syringe Merit Medical Systems, Inc. OAR 2024-12-20 00884450833964 DiamondTOUCH™ Syringe Merit Medical Systems, Inc. OAR 2024-11-16 10884450833961 DiamondTOUCH™ Syringe Merit Medical Systems, Inc. OAR 2024-11-16 00815212026935 Duro-Ject Bone Cement Injection Tube Izi Medical Products, LLC OAR 2024-10-14 08058964724960 VHP GUN G21 SRL OAR 2024-10-14 08033860022396 BIOPSYBELL BIOPSYBELL SRL OAR 2024-02-23 08033860022693 BIOPSYBELL BIOPSYBELL SRL OAR 2024-02-23 10860003533229 IM Nail Dispenser Mold Bonesetter Holdings, LLC OAR 2024-01-10 00860003533239 IM Nail Dispenser Mold Bonesetter Holdings, LLC OAR 2024-01-10