FDA.reportPublic FDA data

Blazer

Primary DI
00813478020247
Brand
Blazer
Company
BENVENUE MEDICAL, INC.
Model
VAK1700
Catalog number
VAK1700
Device description
Vertebral Augmentation Cement Kit for Use with Blazer-C
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDNCement, Bone, Vertebroplasty
OARInjector, Vertebroplasty (Does Not Contain Cement)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDNCement, Bone, VertebroplastyOrthopedic2
OARInjector, Vertebroplasty (Does Not Contain Cement)Orthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813478020247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813478020247008134780202478134780202470813478020247

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement preparation/delivery kitA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 997-7463info@benvenuemedical.com

Regulatory Flags#

DUNS number
787732689
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813478020001KivaKIV2100KIV21002016-09-24
00813478020018KivaKIV2150KIV21502016-09-24
00813478020025KivaKIV2200KIV22002016-09-24
00813478020032KivaKIV2250KIV22502016-09-24
00813478020049KivaFRS2100FRS21002016-09-24
00813478020056KivaFRS2200FRS22002016-09-24
00813478020414KivaMS3643MS36432016-09-24
00813478020421BlazerMS2079MS20792016-09-24
00813478020438KivaMS3101MS31012016-09-24
00813478020377Luna 3DLUN4000LUN40002016-09-24
00813478020391Luna 3DLUN4200LUN42002016-09-24
00813478020063KivaPLT1900PLT19002016-09-24
00813478020070KivaPLT1910PLT19102016-09-24
00813478020186BlazerBCN3120BCN31202016-09-24
00813478020193BlazerBZK3130BZK31302016-09-24
00813478020087KivaACC1510ACC15102016-09-24
00813478020094KivaACC1520ACC15202016-09-24
00813478020100KivaACC5220ACC52202016-09-24
00813478020117KivaACC5225ACC52252016-09-24
00813478020124KivaACC5230ACC52302016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000750510CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-23
08058964729767Easy Winch 13 G, 15 mmG21 SRLNDN2026-10-19
08058964729774Easy Winch 13 G, 10 mmG21 SRLNDN2026-10-19
00763000750053CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-16
00763000750251CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-16
00763000750268CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-16
00763000750275CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-16
00763000750374CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-16
00763000750404CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-16
08058964728692Winch Kyphoplasty Balloon Catheter 15G 10 mmG21 SRLNDN2026-09-30
08058964728708Winch Kyphoplasty Balloon Catheter 15G 15 mmG21 SRLNDN2026-09-30
08033737113813ADRIA srl - KIT OF 2 CEMENT INJECTION CANNULASADRIA SRLOAR2026-08-25
06937321301384Gun-shaped Bone Cement Filler DevicesShanghai Lange Medtech Co., Ltd.OAR2026-06-18
00884450843215StabiliT®Merit Medical Systems, Inc.NDN2026-04-15
00884450843222StabiliT®Merit Medical Systems, Inc.NDN2026-03-31
03701505801204DynamoTEKNIMEDNDN2026-02-02
04260102139411OSTEOPAL®Heraeus Medical GmbHNDN2025-09-26
08053175003439Vertebroplasty Injector KitADRIA SRLOAR2025-04-07
00815212026966OS 11G BONE FILLER KIT-OSTEOFIXIzi Medical Products, LLCNDN2025-03-26
00889095358230CONCORDGLOBUS MEDICAL, INC.NDN2024-12-01
00889095358247CONCORDGLOBUS MEDICAL, INC.NDN2024-12-01
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONNDN2024-11-21
00884450833964DiamondTOUCH™ SyringeMerit Medical Systems, Inc.OAR2024-11-16
00815212026935Duro-Ject Bone Cement Injection TubeIzi Medical Products, LLCOAR2024-10-14
07613327638233OmnicurveSTRYKER CORPORATIONNDN2024-09-03
00815212026911KIT:BALLOON AND BONE FILLERIzi Medical Products, LLCNDN2024-08-28
00815212026928KIT:BALLOON,FILLER,ACCESS,DRILLIzi Medical Products, LLCNDN2024-08-28
00815212026775Vertefix MVIzi Medical Products, LLCNDN2024-02-16
00815212026782Osteo-site VCF Kit, Vertefix MV CementIzi Medical Products, LLCNDN2024-02-16