Home GUDID 08053175003439 Vertebroplasty Injector Kit
Primary DI 08053175003439
Brand Vertebroplasty Injector Kit
Company ADRIA SRL
Model 49000001
Device description Vertebroplasty Set
Published 2025-04-07
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 08053175003439 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08053175003439 08053175003439 8053175003439
GMDN Terms# Term, Definition table Term Definition Orthopaedic cement/bone filler dispensing gun A hand-operated device designed to hold an orthopaedic cement/filler syringe/cartridge and to facilitate the dispensing of the substance to the application site or an application device. It is a pistol-like device with a barrel recess, to place the syringe/cartridge, which includes a trigger mechanism to force the substance from the distal end, and may include graduated markings to dispense the substance in discrete quantities. This is a reusable device.
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 437941789 Device count 1 Premarket exempt true Kit true Lot or batch true Manufacturing date on label true Expiration 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 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 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 08800038054332 MEDINAUT-V IMEDICOM CO., LTD. OAR 2023-08-31