Home GUDID 08800038055681 SYNTH™ VRT
Primary DI 08800038055681
Brand SYNTH™ VRT
Company IMEDICOM CO., LTD.
Model SYNTH-V150
Device description HC Biologics Private Label(11G-150)
Published 2023-08-30
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
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 08800038055681 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800038055681 08800038055681 8800038055681
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 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08053175003439 Vertebroplasty Injector Kit ADRIA SRL OAR 2025-04-07 08053175004382 Cement Injection Cannula ADRIA SRL OAR 2025-04-07 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 10884450837549 StabiliT TOUCH™ Syringe Merit Medical Systems, Inc. OAR 2024-12-20 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 08033860022693 BIOPSYBELL BIOPSYBELL SRL OAR 2024-02-23 08800038054332 MEDINAUT-V IMEDICOM CO., LTD. OAR 2023-08-31 08800038054349 MEDINAUT-V IMEDICOM CO., LTD. OAR 2023-08-31 08800038055674 SYNTH™ VRT IMEDICOM CO., LTD. OAR 2023-08-30 00884450492284 StabiliT® Merit Medical Systems, Inc. OAR 2023-07-08 08033860015435 BIOPSYBELL BIOPSYBELL SRL OAR 2023-06-16 08033860017521 BIOPSYBELL BIOPSYBELL SRL OAR 2023-06-16 08033860022419 BIOPSYBELL BIOPSYBELL SRL OAR 2023-06-15 08033860023102 BIOPSYBELL BIOPSYBELL SRL OAR 2023-06-15 08033860026592 BIOPSYBELL BIOPSYBELL SRL OAR 2023-06-15 08033860034740 BIOPSYBELL BIOPSYBELL SRL OAR 2023-06-15 08033860039417 BIOPSYBELL BIOPSYBELL SRL OAR 2023-06-15 10884450662141 StabiliT TOUCH™ Syringe Merit Medical Systems, Inc. OAR 2022-10-04 08033860030223 BIOPSYBELL BIOPSYBELL SRL OAR 2022-09-29 08033860036591 BIOPSYBELL BIOPSYBELL SRL OAR 2022-09-29 08033860024567 BIOPSYBELL BIOPSYBELL SRL OAR 2022-09-28 28031497001702 MENDEC AQUA TECRES SPA OAR 2022-09-23 28031497002006 MENDEC AQUA CARTRIDGE TECRES SPA OAR 2022-09-23 08033860016739 BIOPSYBELL BIOPSYBELL SRL OAR 2022-09-19 08033860016760 BIOPSYBELL BIOPSYBELL SRL OAR 2022-09-19 08033860019501 BIOPSYBELL BIOPSYBELL SRL OAR 2022-09-19