FDA.reportPublic FDA data

Duro-Ject Bone Cement Injection Tube

Primary DI
00815212026935
Brand
Duro-Ject Bone Cement Injection Tube
Company
Izi Medical Products, LLC
Model
G13550
Published
2024-10-14
Public version status
New
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
OARInjector, Vertebroplasty (Does Not Contain Cement)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815212026935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815212026935008152120269358152120269350815212026935

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B8872150044X-Seed2150042150042020-04-30
B8872850033X-Seed2850032850032020-04-30
B8872850044X-Seed2850042850042020-04-30
B887GF10033VISICOIL MRGF1003GF10032021-09-17
B887GF10044VISICOIL MRGF1004GF10042021-09-17
B887GF13233VISICOIL MRGF1323GF13232021-09-17
B887GF15033Gold FiducialGF1503GF15032021-09-17
B887MR250100VISICOIL MRMR-250102025-10-22
B887MR275100Platinum Fiducial MarkerMR-275102025-10-22
B887MR275515180Platinum Fiducial MarkerMR-275-515182025-10-22
B887MR375050Platinum Fiducial MarkerMR-375052025-10-22
B887MR475050Platinum Fiducial MarkerMR-475052025-10-22
SNMR05000521200VISICOIL MRSNMR-050-005-2120SNMR-050-005-21202022-05-13
B887MR050020PL0VISICOIL MRMR-050-020-PLMR-050-020-PL2022-12-07
B887MR05000519200VISICOIL MRMR-050-005-1920MR-050-005-19202022-11-25
B887MR05001019200VISICOIL MRMR-050-010-1920MR-050-010-19202022-09-14
B887001062X-MARK Ultra0010620010622022-07-18
B887SHZ035020220VISICOIL MRSHZ-035-020-22SHZ-035-020-222022-07-18
B887SN035005PL200VISICOILSN-035-005-PL20SN-035-005-PL202022-07-18
B887SN035010PL200VISICOILSN-035-010-PL20SN-035-010-PL202022-07-18

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
08058964729163KeyFix_FILLER CANNULA FOR FENESTRATED SCREW 8-16 GG21 SRLOAR2026-05-05
03701505801211DynamoTEKNIMEDOAR2026-02-02
03701505801228DynamoTEKNIMEDOAR2026-02-02
03701505801235DynamoTEKNIMEDOAR2026-02-02
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
06923558507569Kyphoplasty Tool KitJiangsu Changmei Medtech Co., Ltd.OAR2025-10-23
06923558509693Kyphoplasty Tool KitJiangsu Changmei Medtech Co., Ltd.OAR2025-10-23
08053175003439Vertebroplasty Injector KitADRIA SRLOAR2025-04-07
08053175004382Cement Injection CannulaADRIA SRLOAR2025-04-07
03701505801020PureKit Syringe 1.5cc MVTEKNIMEDOAR2025-03-31
03701505801037META+ System 1.5cc MVTEKNIMEDOAR2025-03-31
03701505801075PUREKIT SyringesTEKNIMEDOAR2025-03-31
03701505801082Syringes 4ccTEKNIMEDOAR2025-03-31
03701505801099Syringes 1.5ccTEKNIMEDOAR2025-03-31
03701505800498PureKit Syringe 4cc MVTEKNIMEDOAR2025-03-31
00884450837542StabiliT TOUCH™ SyringeMerit Medical Systems, Inc.OAR2024-12-20
10884450837549StabiliT TOUCH™ SyringeMerit Medical Systems, Inc.OAR2024-12-20
00884450833964DiamondTOUCH™ SyringeMerit Medical Systems, Inc.OAR2024-11-16
10884450833961DiamondTOUCH™ SyringeMerit Medical Systems, Inc.OAR2024-11-16
08058964724960VHP GUNG21 SRLOAR2024-10-14
08033860022396BIOPSYBELLBIOPSYBELL SRLOAR2024-02-23
08033860022693BIOPSYBELLBIOPSYBELL SRLOAR2024-02-23
10860003533229IM Nail Dispenser MoldBonesetter Holdings, LLCOAR2024-01-10