FDA.reportPublic FDA data

DiamondTOUCH™ Syringe

Primary DI
00884450360286
Brand
DiamondTOUCH™ Syringe
Company
Merit Medical Systems, Inc.
Model
00884450360286
Catalog number
IN9VCF
Published
2019-11-18
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
10884450360283PackageGS15In Commercial Distribution
00884450360286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445036028310884450360283
00884450360286008844503602868844503602860884450360286

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.

Regulatory Flags#

DUNS number
184763290
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450376867Merit Medical®Initial ReleaseK09-10502F2026-09-26
00884450431597Merit Medical®Initial ReleaseK09-12862A2026-09-26
00884450432105Merit Medical®Initial ReleaseK09-08926B2026-09-26
00884450707104Merit Medical®DTS1202026-09-26
00884450707111Merit Medical®DTS2202026-09-26
00884450028605Merit Medical®Initial ReleaseK08-01254A2026-09-24
00884450277652Safety Paracentesis Procedure TrayInitial ReleaseSPPT-8F-10S2026-09-22
00884450416723SureCrossDSC18652026-09-22
00884450422755SureCrossDSC14902026-09-22
00884450423110SureCrossDSC14652026-09-22
00884450427170SureCrossDSC141352026-09-22
00884450428016Merit Medical®Initial ReleaseK10-03360H2026-09-22
00884450435526Merit Medical®Initial ReleaseK09-11159A2026-09-22
00884450445419Merit Medical®Initial ReleaseK09-01589X2026-09-22
00884450473313Merit Medical®Initial ReleaseK09-14357A2026-09-22
00884450852279Merit Medical®Initial ReleasePC8112026-09-22
00884450852286Merit Medical®Initial ReleasePC8122026-09-22
10884450489809Prelude SNAP™APLSX-25112026-09-22
10884450489816Prelude SNAP™APLSS-10062026-09-22
10884450489823Prelude SNAP™APLSS-10072026-09-22

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
00815212026935Duro-Ject Bone Cement Injection TubeIzi Medical Products, LLCOAR2024-10-14
08058964724960VHP GUNG21 SRLOAR2024-10-14
08033860022396BIOPSYBELLBIOPSYBELL SRLOAR2024-02-23
08033860022693BIOPSYBELLBIOPSYBELL SRLOAR2024-02-23