FDA.report

VCF-000

Primary DI
00815212024337
Brand
VCF-000
Company
Izi Medical Products, LLC
Model
G80000
Published
2021-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OARInjector, Vertebroplasty (Does Not Contain Cement)

Product Code Classifications

CodeDeviceSpecialtyClass
OARInjector, Vertebroplasty (Does Not Contain Cement)Orthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815212024337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815212024337008152120243378152120243370815212024337

GMDN Terms

TermDefinition
Orthopaedic cement dispenserA syringe-like device intended for use in placing orthopaedic bone cement into surgical sites. Cement dispensers may be manually-operated or mounted in a powered unit that drives the piston down the syringe barrel. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
933506164
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

Primary DIBrandModelCatalogPublished
00815212026973BLAZER-C CURVED INJECTION SYSTEM-MVBZK31602025-05-21
00815212026966OS 11G BONE FILLER KIT-OSTEOFIXG800122025-03-26
00815212026942BKP-10-12.0-15.0-BG10015B2025-01-08
00815212026959BKP-11-12.0-15.0-BG11015B2025-01-08
00815212026935Duro-Ject Bone Cement Injection TubeG135502024-10-14
00815212026911KIT:BALLOON AND BONE FILLERVBBF0012024-08-28
00815212026928KIT:BALLOON,FILLER,ACCESS,DRILLVBBF0022024-08-28
10815212026895OsteoPearl Vertebral Balloon (15mm), 10G100.4122024-08-05
00815212026904OsteoPearl Vertebral Balloon (15mm) & Inflation Device Kit, 10G100.4102024-08-05
00815212024467STRYKER NAVIGATED BIOPSY NEEDLE6000-805-8002024-07-30
00815212026874BKP-10-12.0-15.0-AG10015A2024-06-28
00815212026881BKP-11-12.0-15.0-AG11015A2024-06-28
00815212026867MDT NAVIGATED BIOPSY, COMPATIABLE 7DMB3000-7D-I2024-03-18
00815212026812ONPOINT NAVIGATION KITDK02101012024-02-27
00815212026829ONPOINT NAVIGATION TRAYDP02101012024-02-27
00815212026836ONPOINT SNAP SPHERZ 25PKDS02125012024-02-27
00815212026843ONPOINT SPHERZ PASSIVE MARKER-12 PACKDS02112012024-02-27
00815212026850ONPOINT PEDICLE ACCESS NEEDLEDJ02101012024-02-27
10815212026819ONPOINT NAVIGATION 10 BOXDK02110012024-02-27
20815212026816ONPOINT NAVIGATION 25 BOXESDK02125012024-02-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08053175003439Vertebroplasty Injector KitADRIA SRLOAR2025-04-07
08053175004382Cement Injection CannulaADRIA SRLOAR2025-04-07
03701505801075PUREKIT SyringesTEKNIMEDOAR2025-03-31
03701505801082Syringes 4ccTEKNIMEDOAR2025-03-31
03701505801099Syringes 1.5ccTEKNIMEDOAR2025-03-31
10884450837549StabiliT TOUCH™ SyringeMerit Medical Systems, Inc.OAR2024-12-20
10884450833961DiamondTOUCH™ SyringeMerit Medical Systems, Inc.OAR2024-11-16
00815212026935Duro-Ject Bone Cement Injection TubeIzi Medical Products, LLCOAR2024-10-14
08058964724960VHP GUNG21 SRLOAR2024-10-14
08033860022693BIOPSYBELLBIOPSYBELL SRLOAR2024-02-23
08800038054332MEDINAUT-VIMEDICOM CO., LTD.OAR2023-08-31
08800038054349MEDINAUT-VIMEDICOM CO., LTD.OAR2023-08-31
08800038055674SYNTH™ VRTIMEDICOM CO., LTD.OAR2023-08-30
08800038055681SYNTH™ VRTIMEDICOM CO., LTD.OAR2023-08-30
00884450492284StabiliT®Merit Medical Systems, Inc.OAR2023-07-08
08033860015435BIOPSYBELLBIOPSYBELL SRLOAR2023-06-16
08033860017521BIOPSYBELLBIOPSYBELL SRLOAR2023-06-16
08033860022419BIOPSYBELLBIOPSYBELL SRLOAR2023-06-15
08033860023102BIOPSYBELLBIOPSYBELL SRLOAR2023-06-15
08033860026592BIOPSYBELLBIOPSYBELL SRLOAR2023-06-15
08033860034740BIOPSYBELLBIOPSYBELL SRLOAR2023-06-15
08033860039417BIOPSYBELLBIOPSYBELL SRLOAR2023-06-15
10884450662141StabiliT TOUCH™ SyringeMerit Medical Systems, Inc.OAR2022-10-04
08033860030223BIOPSYBELLBIOPSYBELL SRLOAR2022-09-29
08033860036591BIOPSYBELLBIOPSYBELL SRLOAR2022-09-29
08033860024567BIOPSYBELLBIOPSYBELL SRLOAR2022-09-28
28031497001702MENDEC AQUATECRES SPAOAR2022-09-23
28031497002006MENDEC AQUA CARTRIDGE TECRES SPAOAR2022-09-23
08033860016739BIOPSYBELLBIOPSYBELL SRLOAR2022-09-19
08033860016760BIOPSYBELLBIOPSYBELL SRLOAR2022-09-19