FDA.reportPublic FDA data

Monoject

Primary DI
50192253037539
Brand
Monoject
Company
Cardinal Health 200, LLC
Model
8881401171
Catalog number
8881401171
Device description
Dental Needle Metal Hub 30 G Extra Short x 1/2" (0.3 x 13 mm)
Published
2026-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZMNEEDLE, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZMNeedle, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253037539PackageGS110In Commercial Distribution
20192253037538PrimaryGS10
10192253037531Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225303753950192253037539
2019225303753820192253037538
1019225303753110192253037531

GMDN Terms#

Term, Definition table
TermDefinition
Dental syringe needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument with an integral hub, typically intended to be attached to a dental cartridge syringe for the injection of local anaesthetics. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0.5Inch
Needle Gauge30Gauge

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126508218Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCDZM2026-03-11
00810126508225Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCDZM2026-03-11
50192253037430MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037454MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037461MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037478MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037492MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037515MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037522MonojectCardinal Health 200, LLCDZM2026-02-10
00840456213629JMUJMU DENTAL, INCDZM2025-12-22
00840456213636JMUJMU DENTAL, INCDZM2025-12-22
00840456213643JMUJMU DENTAL, INCDZM2025-12-22
00840456213650JMUJMU DENTAL, INCDZM2025-12-22
00841336101029Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCDZM2025-11-11
00842517112360Karl SchumacherKarl Schumacher Dental, LLCDZM2025-07-08
00842517112384Karl SchumacherKarl Schumacher Dental, LLCDZM2025-07-08
00842517112421Karl SchumacherKarl Schumacher Dental, LLCDZM2025-07-08
00842517112476Karl SchumacherKarl Schumacher Dental, LLCDZM2025-07-08
00842517112483Karl SchumacherKarl Schumacher Dental, LLCDZM2025-07-08
08800123817903V-JectVERICOM CO., LTD.DZM2025-06-25
08800123817941V-JectVERICOM CO., LTD.DZM2025-06-25
08800123817965V-JectVERICOM CO., LTD.DZM2025-06-25
06936018502202baixinAnhui Kangda Medical Products Co.,Ltd.DZM2025-05-28
06936018502257baixinAnhui Kangda Medical Products Co.,Ltd.DZM2025-05-28
G001HSB1071100House BrandChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.DZM2024-09-06
86974456210057CICADAFoshan Cicada Dental Instrument Co., Ltd.DZM2024-08-10
86974456210217CICADAFoshan Cicada Dental Instrument Co., Ltd.DZM2024-08-10
86974456210224CICADAFoshan Cicada Dental Instrument Co., Ltd.DZM2024-08-10
G001HSB1071102House Brand DentistryChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.DZM2024-06-05
08053610772814SIRIOTECNOFAR SPADZM2024-05-27