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
00813478020377Luna 3DLUN4000LUN40002016-09-24
00813478020391Luna 3DLUN4200LUN42002016-09-24
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
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
08033737113813ADRIA srl - KIT OF 2 CEMENT INJECTION CANNULASADRIA SRLOAR2026-08-25
00884450587713StabiliT®Merit Medical Systems, Inc.OAR2026-07-30
08809695579813Trocar Needle (Working Channel)GS Medical Co., Ltd.NDN2026-07-27
08809695579820Bevel Needle (Working Channel)GS Medical Co., Ltd.NDN2026-07-27
08058964729163KeyFix_FILLER CANNULA FOR FENESTRATED SCREW 8-16 GG21 SRLOAR2026-05-05
08031497003689Mendec® Kypho Set Monolateral 10 mmTECRES SPAOAR2025-12-17
08031497003696Mendec® Kypho Set Monolateral 15 mmTECRES SPAOAR2025-12-17
08031497003702Mendec® Kypho Set Monolateral 20 mmTECRES SPAOAR2025-12-17
08031497003801Mendec® Kypho Set Bilateral 10 mmTECRES SPAOAR2025-12-17
08031497003818Mendec® Kypho Set Bilateral 15 mmTECRES SPAOAR2025-12-17
08031497003825Mendec® Kypho Set Bilateral 20 mmTECRES SPAOAR2025-12-17
08058964726452Winch Kyphoplasty Kit 15 mmG21 SRLNDN2025-02-26
08058964726469Winch Kyphoplasty Kit 20 mmG21 SRLNDN2025-02-26
08058964726735Winch Kyphoplasty Bilateral Kit 15 mmG21 SRLNDN2025-02-26
08058964727589EasyWinch 15 mmG21 SRLNDN2025-02-26
08058964727596EasyWinch 20 mmG21 SRLNDN2025-02-26
08058964727763Winch Kyphoplasty Kit 8G 15 mmG21 SRLNDN2025-02-26
08058964727770Winch Kyphoplasty Bilateral Kit 8G 15 mmG21 SRLNDN2025-02-26
08058964727787Winch Kyphoplasty Kit 8G 20 mmG21 SRLNDN2025-02-26
08058964727794Winch Kyphoplasty Bilateral Kit 8G 20 mmG21 SRLNDN2025-02-26
08058964727817Winch Kyphoplasty Bilateral Kit 20 mmG21 SRLNDN2025-02-26
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONNDN2024-11-21
07613327638226OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638233OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638240OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638257OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638431OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638448OmnicurveSTRYKER CORPORATIONNDN2024-09-03
08033860030179BIOPSYBELLBIOPSYBELL SRLNDN2024-02-26
08033860022396BIOPSYBELLBIOPSYBELL SRLOAR2024-02-23