FDA.reportPublic FDA data

Monoject

Primary DI
10884521010444
Brand
Monoject
Company
Cardinal Health, Inc.
Model
8881471273
Catalog number
8881471273
Device description
Endodontic Needle
Published
2018-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EICSYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EICSyringe, Periodontic, Endodontic, IrrigatingDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521010441PackageGS1100In Commercial Distribution
40884521010445PackageGS12800In Commercial Distribution
10884521010444PrimaryGS10
50884521010442Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452101044120884521010441
4088452101044540884521010445
1088452101044410884521010444
5088452101044250884521010442

GMDN Terms#

Term, Definition table
TermDefinition
Dental irrigation/aspiration syringeA hand-held manual dental device (a plunger-type syringe) designed to inject and/or aspirate a volume of solution into the working area in the oral cavity. It typically consists of a small syringe (e.g., 3 ml) and is used for washing and aspirating the pulp cavity and root canal to remove debris. It is hand-operated by the user who exerts a steady pressure on, e.g., thumb rings and/or swivel finger bars, which exerts pressure on the syringe plunger forcing the washing/rinsing fluids through an attached needle (e.g., a blunt or very fine needle) directly at the operative site. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length1.25Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry;AVOID DIRECT SUNLIGHT

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
Device count
25
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30884527004847KendallES82417ES824172016-09-24
30884521024841Kendall923692362018-06-30
10884521138247Devon31146891311468912016-09-24
10884521138261Devon31146893311468932016-09-24
10884521154094Devon31146894311468942016-09-24
10884521154100Devon31146895311468952016-09-24
10192253059984Dover7014MF7014MF2022-06-07
10884521013230Monoject888122524188812252412016-09-24
10884521013254Monoject888122524588812252452016-09-24
10884521024854Kendall923892382018-06-27
10884521004498Dover1455001455002016-09-24
10884521014091Monoject888150164088815016402016-09-24
10884521163041Magellan888185005888818500582016-09-24
10884527021932Uni-PatchEP84580EP845802016-09-24
20884521012216Monoject888153578888815357882016-09-24
20884521012254Monoject888156018288815601822016-09-24
20884521014159Monoject888151613588815161352016-10-13
10884521518889Kangaroo888472109688847210962016-09-24
10884521015791Dover888762312588876231252016-09-24
10884521015920Dover20512C20512C2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB71040TBS BASICSACME ENTERPRISE.EIC2026-05-22
00371347023466Advance Dental ProductsThe Atlanta Dental Supply CompanyEIC2026-04-14
00371347023473Advance Dental ProductsThe Atlanta Dental Supply CompanyEIC2026-04-14
G1493807003TBS DentalACME ENTERPRISE.EIC2026-03-02
00850014374983MARK3®CARGUS INTERNATIONAL, INCEIC2026-02-05
00850014374990MARK3®CARGUS INTERNATIONAL, INCEIC2026-02-05
00850440008339IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008346IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008353IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008360IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008377IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008384IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008391ES Cap TipsEngineered Endodontics, LLCEIC2026-01-02
00850440008513ES VacEngineered Endodontics, LLCEIC2026-01-02
00850440008520ES VacEngineered Endodontics, LLCEIC2026-01-02
00850440008537ES VacEngineered Endodontics, LLCEIC2026-01-02
00850440008551JS IrriGator Engineered Endodontics, LLCEIC2026-01-02
00850440008568JS IrriGator Engineered Endodontics, LLCEIC2026-01-02
00850440008575JS IrriGator Engineered Endodontics, LLCEIC2026-01-02
008504400086433DPD Paste Delivery TipEngineered Endodontics, LLCEIC2026-01-02
00850440008650Capillary Tip - PremiumEngineered Endodontics, LLCEIC2026-01-02
00850440008667IrriGator Flex TipEngineered Endodontics, LLCEIC2026-01-02
00841336109438Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIC2025-11-11
00810118106439NuSmile NuNamel Pit & Fissure Sealant Brush TipNUSMILE, LTD.EIC2025-07-24
00810118106446NuSmile NuNamel Pit & Fissure Sealant Brush TipNUSMILE, LTD.EIC2025-07-24
00810118106453NuSmile NuNamel Pit & Fissure Sealant Brush TipNUSMILE, LTD.EIC2025-07-24
00810118106521Avalon Biomed Clear Flex Tips - 4 PackNUSMILE, LTD.EIC2025-07-15
00810118106538Avalon Biomed Clear Flex Tips - 20 PackNUSMILE, LTD.EIC2025-07-15
00810118106545Avalon Biomed Clear Flex Tips - 40 PackNUSMILE, LTD.EIC2025-07-15
00883205033123NaviTip 29G SideportULTRADENT PRODUCTS, INC.EIC2025-03-11