FDA.reportPublic FDA data

Vertebroplasty Injector

Primary DI
00815212023293
Brand
Vertebroplasty Injector
Company
Izi Medical Products, LLC
Model
G32497 - DURO-100
Published
2018-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KNWInstrument, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815212023293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815212023293008152120232938152120232930815212023293

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement, non-medicatedA substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene. This device does not contain an antimicrobial agent. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
933506164
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B8870010690X-MARK Ultra0010690010692022-06-17
EIBA10010X-Mark100110012016-09-23
EIBA10020X-Mark100210022016-09-23
EIBA10070X-MArk100710072016-09-23
EIBA10080X-Mark100810082016-09-23
EIBA10090X-Mark100910092016-09-23
EIBA10210X-Mark102110212016-09-23
EIBA10220X-Mark102210222016-09-23
EIBA10230X-Mark102310232016-09-23
EIBA10270X-Mark102710272016-09-23
EIBA10280X-Mark102810282016-09-23
EIBA10290X-Mark102910292016-09-23
EIBA10400X-Mark104010402017-03-16
EIBA10410X-Mark104110412016-09-23
EIBA10420X-Mark104210422016-09-23
EIBA10470X-Mark104710472016-09-23
EIBA10600X-Mark Ultra106010602016-09-23
EIBA10610X-Mark Ultra106110612016-09-23
EIBA10620X-Mark Ultra106210622016-09-23
EIBA10670X-Mark Ultra106710672016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450831554Tru-Cut®Merit Medical Systems, Inc.KNW2026-07-08
00884450397961TEMNO Elite™Merit Medical Systems, Inc.KNW2026-06-10
00841911103776Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-06-09
08800025901151BEXCORE Breast Biopsy SystemMedicalPark CO.,LTD.KNW2026-06-01
08800025902059BEXCORE Breast Biopsy SystemMedicalPark CO.,LTD.KNW2026-06-01
06937278635983CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278635990CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636003CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636010CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636027CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636034CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636041CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636058CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636065CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636072CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636089CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636096CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636102CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636119CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636126CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636133CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636140CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636157CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636164CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636171CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636188CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636195CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636201CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636218CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636225CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31