FDA.reportPublic FDA data

DFINE®

Primary DI
00884450296400
Brand
DFINE®
Company
Merit Medical Systems, Inc.
Model
00884450296400
Catalog number
3610/A
Published
2018-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NDNCEMENT, BONE, VERTEBROPLASTY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDNCement, Bone, VertebroplastyOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450296407PackageGS11In Commercial Distribution
00884450296400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445029640710884450296407
00884450296400008844502964008844502964000884450296400

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement dispensing controllerA mains electricity (AC-powered), electromechanical, bench-top unit designed to drive orthopaedic bone cement through a connected hydraulic cement dispensing device (e.g., syringe, dispensing gun) during arthroplastic/osteosynthetic procedures (e.g., vertebroplasty, kyphoplasty). It may additionally be intended to regulate the temperature of the cement to help modulate its viscosity during delivery.

Regulatory Flags#

DUNS number
184763290
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450431542Merit Medical®Initial ReleaseK09-10472B2026-10-24
00884450459386MAK-NV™DMAK-NV-0182026-10-23
00884450499252Merit S-MAK™HS-MAK401N2026-10-24
10884450438777Prelude® Short SheathBPSS-7F-4MT2026-10-23
10884450834340Prelude EASE™GPHR4F11018SS2026-10-24
00884450161692Merit Medical®Initial ReleaseK09-10791D2026-10-22
00884450428238Merit Medical®Initial ReleaseK10-00125M2026-10-22
00884450435700Merit Medical®Initial ReleaseK10-04943A2026-10-22
00884450499214Merit Medical®Initial ReleaseK12T-02975G2026-10-22
00884450501023Merit Medical®Initial ReleaseK12T-127572026-10-22
00884450501047Merit Medical®Initial ReleaseK10-06118G2026-10-22
00884450501054Merit Medical®Initial ReleaseK09-05248Q2026-10-22
00884450501078Merit Medical®Initial ReleaseK10-00389R2026-10-22
00884450501085Merit Medical®Initial ReleaseK09-14184F2026-10-22
00884450502075Merit Medical®Initial ReleaseK10-03143F2026-10-22
00884450502082Merit Medical®Initial ReleaseK12T-09122J2026-10-22
00884450502556Merit Medical®Initial ReleaseK09-144532026-10-22
00884450502891Merit Medical®Initial ReleaseK09-05181J2026-10-22
00884450502921Merit Medical®Initial ReleaseK09-12476F2026-10-22
00884450502938Merit Medical®Initial ReleaseK09-14208C2026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000749903CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-23
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
08809695579813Trocar Needle (Working Channel)GS Medical Co., Ltd.NDN2026-07-27
08809695579820Bevel Needle (Working Channel)GS Medical Co., Ltd.NDN2026-07-27
03701505801204DynamoTEKNIMEDNDN2026-02-02
08800038029323SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029330SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029347SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029354SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
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