FDA.reportPublic FDA data

Monoject

Primary DI
50192253037492
Brand
Monoject
Company
Cardinal Health 200, LLC
Model
8881401049
Catalog number
8881401049
Device description
Dental Needle Metal Hub 25 G Short x 1" (0.5 x 25 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
50192253037492PackageGS110In Commercial Distribution
20192253037491PrimaryGS10
10192253037494Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225303749250192253037492
2019225303749120192253037491
1019225303749410192253037494

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
Length1Inch
Needle Gauge25Gauge

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
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
20192253037422MonojectCardinal Health 200, LLCDZM2026-04-02