FDA.report

DiamondTOUCH™ Syringe

Primary DI
10884450360283
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
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OARInjector, vertebroplasty (does not contain cement)

Product Code Classifications

CodeDeviceSpecialtyClass
OARInjector, Vertebroplasty (Does Not Contain Cement)Orthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10884450360283PackageGS15In Commercial Distribution
00884450360286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445036028310884450360283
00884450360286008844503602868844503602860884450360286

GMDN Terms

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

Regulatory Flags

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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00884450392898SCOUT MD™Initial ReleaseMDS10A-012026-05-23
00884450392904SCOUT MD™Initial ReleaseMDS10B-012026-05-23
00884450392911SCOUT MD™Initial ReleaseMDS10C-012026-05-23
00884450393383SCOUT MD™Initial ReleaseMDS75SA-012026-05-23
00884450399965SCOUT MD™Initial ReleaseMDS75SM-012026-05-23
00884450435120Merit Medical®Initial ReleaseK09-10345A2026-05-22
00884450435533Merit Medical®Initial ReleaseK07-00112C2026-05-23
00884450437049Merit Medical®Initial ReleaseK11-01136C2026-05-23
00884450437162Merit Medical®Initial ReleaseK09-10786C2026-05-22
00884450441350Merit Medical®Initial ReleaseK09-14004B2026-05-23
00884450474587Merit Medical®Initial ReleaseK12T-127142026-05-23
10884450029364Merit Medical®Initial ReleaseK08-02142B2026-03-24
10884450111731Merit Medical®Initial ReleaseK09-11186D2026-03-24
00884450220696Merit Medical®Initial ReleaseK05T-02138B2026-03-24
10884450423629Merit Medical®Initial ReleaseK09-13891B2026-03-24
10884450425333Merit Medical®Initial ReleaseK10-01481A2026-03-24
20884450430815Merit Medical®Initial ReleaseK09-05342B2026-03-24
10884450430863Merit Medical®Initial ReleaseK09-10929A2026-03-24
00884450458426DuraMax®BH7871030282252026-03-24
10884450529581SplashWire™Initial ReleaseMSWSTFS352202026-03-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08053175003439Vertebroplasty Injector KitADRIA SRLOAR2025-04-07
08053175004382Cement Injection CannulaADRIA SRLOAR2025-04-07
03701505801075PUREKIT SyringesTEKNIMEDOAR2025-03-31
03701505801082Syringes 4ccTEKNIMEDOAR2025-03-31
03701505801099Syringes 1.5ccTEKNIMEDOAR2025-03-31
10884450837549StabiliT TOUCH™ SyringeMerit Medical Systems, Inc.OAR2024-12-20
10884450833961DiamondTOUCH™ SyringeMerit Medical Systems, Inc.OAR2024-11-16
00815212026935Duro-Ject Bone Cement Injection TubeIzi Medical Products, LLCOAR2024-10-14
08058964724960VHP GUNG21 SRLOAR2024-10-14
08033860022693BIOPSYBELLBIOPSYBELL SRLOAR2024-02-23
08800038054332MEDINAUT-VIMEDICOM CO., LTD.OAR2023-08-31
08800038054349MEDINAUT-VIMEDICOM CO., LTD.OAR2023-08-31
08800038055674SYNTH™ VRTIMEDICOM CO., LTD.OAR2023-08-30
08800038055681SYNTH™ VRTIMEDICOM CO., LTD.OAR2023-08-30
00884450492284StabiliT®Merit Medical Systems, Inc.OAR2023-07-08
08033860015435BIOPSYBELLBIOPSYBELL SRLOAR2023-06-16
08033860017521BIOPSYBELLBIOPSYBELL SRLOAR2023-06-16
08033860022419BIOPSYBELLBIOPSYBELL SRLOAR2023-06-15
08033860023102BIOPSYBELLBIOPSYBELL SRLOAR2023-06-15
08033860026592BIOPSYBELLBIOPSYBELL SRLOAR2023-06-15
08033860034740BIOPSYBELLBIOPSYBELL SRLOAR2023-06-15
08033860039417BIOPSYBELLBIOPSYBELL SRLOAR2023-06-15
10884450662141StabiliT TOUCH™ SyringeMerit Medical Systems, Inc.OAR2022-10-04
08033860030223BIOPSYBELLBIOPSYBELL SRLOAR2022-09-29
08033860036591BIOPSYBELLBIOPSYBELL SRLOAR2022-09-29
08033860024567BIOPSYBELLBIOPSYBELL SRLOAR2022-09-28
28031497001702MENDEC AQUATECRES SPAOAR2022-09-23
28031497002006MENDEC AQUA CARTRIDGE TECRES SPAOAR2022-09-23
08033860016739BIOPSYBELLBIOPSYBELL SRLOAR2022-09-19
08033860016760BIOPSYBELLBIOPSYBELL SRLOAR2022-09-19