FDA.reportPublic FDA data

Monoject

Primary DI
20192253068877
Brand
Monoject
Company
Cardinal Health 200, LLC
Model
8881412012
Catalog number
8881412012
Device description
Curved Tip Syringe 12mL
Published
2026-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
EIBSyringe, irrigating (dental)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIBSyringe, Irrigating (Dental)Dental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253068878PackageGS110In Commercial Distribution
20192253068877PrimaryGS10
10192253068870Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225306887850192253068878
2019225306887720192253068877
1019225306887010192253068870

GMDN Terms#

Term, Definition table
TermDefinition
Irrigation syringeA general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume12Milliliter

Regulatory Flags#

DUNS number
961027315
Device count
50
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
10198956038127CARDINAL HEALTHSAN22IAMRASAN22IAMRA2026-10-19
10198956180000CARDINAL HEALTHPUV2KPMHBPUV2KPMHB2026-10-19
10198956268111CARDINAL HEALTHSNECGACSGESNECGACSGE2026-10-19
10198956377967CARDINAL HEALTHSBA56MIMCFSBA56MIMCF2026-10-19
10198956384774CARDINAL HEALTHSVA42LVGLCSVA42LVGLC2026-10-19
10198956390799CARDINAL HEALTHSEYCGEPAZBSEYCGEPAZB2026-10-19
10198956400795CARDINAL HEALTHSOP3MKPCVDSOP3MKPCVD2026-10-19
10198956414815CARDINAL HEALTHSMA41PGEPBSMA41PGEPB2026-10-19
10198956441811CARDINAL HEALTHSCV29VPPCUSCV29VPPCU2026-10-19
10198956462328CARDINAL HEALTHSCV13PPBTESCV13PPBTE2026-10-19
10198956464988CARDINAL HEALTHSOP51XRKKPSOP51XRKKP2026-10-19
10198956499270CARDINAL HEALTHPG33BGMKBPG33BGMKB2026-10-19
10198956499980CARDINAL HEALTH33-2528E33-2528E2026-10-19
10198956506732CARDINAL HEALTHSOP41TPDSFSOP41TPDSF2026-10-19
10198956513587CARDINAL HEALTHSAN33CACHNSAN33CACHN2026-10-19
10198956514874CARDINAL HEALTHSOPOCTKSBBSOPOCTKSBB2026-10-19
10198956516922CARDINAL HEALTHPC23TAAMEPC23TAAME2026-10-19
10198956518964CARDINAL HEALTHSAN40CCAEGSAN40CCAEG2026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456200957JMUJMU DENTAL, INCEIB2026-07-27
00840456215135JMUJMU DENTAL, INCEIB2026-07-27
50192253068878MonojectCardinal Health 200, LLCEIB2026-01-29
G001HSB107114House BrandChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-09-06
G001HSB1071150House BrandChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-09-06
G001HSB1071190House BrandChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-09-06
G001HSB1072000House BrandChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-09-06
00840183524234BR Surgical, LLCBR Surgical, LLCEIB2024-06-10
D974BSI10191BritedentBright Supply, Inc.EIB2024-06-07
D974BSI10211BritedentBright Supply, Inc.EIB2024-06-07
D974BSI10251BritedentBright Supply, Inc.EIB2024-06-07
D974BSI10190BritedentBright Supply, Inc.EIB2024-06-07
D974BSI10210BritedentBright Supply, Inc.EIB2024-06-07
D974BSI10250BritedentBright Supply, Inc.EIB2024-06-07
G001HSB1071140House Brand DentistryChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-06-05
G001HSB1071151House Brand DentistryChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-06-05
G001HSB1072001House Brand DentistryChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-06-05
G001HSB1071141House Brand DentistryChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-06-05
G001HSB1071152House Brand DentistryChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-06-05
G001HSB1072002House Brand DentistryChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.EIB2024-06-05
D974BSI10181BritedentBright Supply, Inc.EIB2024-04-08
D974BSI10180BritedentBright Supply, Inc.EIB2024-04-08
08964003163785Doctor NiceB. Ali ImpexEIB2024-01-29
08964003163433NivoB. Ali ImpexEIB2024-01-27
G002HSB107110House brand SHIFENG MEDICAL TECHNOLOGY CO.，LTD.EIB2023-05-10
10850002458166Advance Dental ProductsThe Atlanta Dental Supply CompanyEIB2023-02-10
20850002458163Advance Dental ProductsThe Atlanta Dental Supply CompanyEIB2023-02-10
10665973030491UnipackUNIPACK MEDICAL CORPORATIONEIB2022-12-06
10665973030507UnipackUNIPACK MEDICAL CORPORATIONEIB2022-12-06
10665973030514UnipackUNIPACK MEDICAL CORPORATIONEIB2022-12-06