FDA.reportPublic FDA data

Monoject

Primary DI
20192253037422
Brand
Monoject
Company
Cardinal Health 200, LLC
Model
8881400033
Catalog number
8881400033
Device description
"Dental Needle Plastic Hub with Metal Insert 25 G Long x 1-1/4"" (0.5 x 32 mm)"
Published
2026-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
50192253037423PackageGS110In Commercial Distribution
20192253037422PrimaryGS10
10192253037425Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225303742350192253037423
2019225303742220192253037422
1019225303742510192253037425

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
Length1.25Inch
Needle Gauge25Gauge

Regulatory Flags#

DUNS number
961027315
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D832BLT100501PlasdentPLASDENT CORPORATIONDZM2026-05-28
D1250802Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D1250812Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D1250822Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D125YS10012Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D125YS10022Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D125YS10072Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D125YS10122Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D832BLT1011PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT2001PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT2011PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT3001PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT3011PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT3021PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4181PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4201PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4211PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4221PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4231PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4251PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4271PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT5221PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT522B1PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT5231PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT523B1PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT5251PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT525B1PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT6301PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT630M1PlasdentPLASDENT CORPORATIONDZM2026-05-01
20192253037446MonojectCardinal Health 200, LLCDZM2026-04-02