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Monoject 8881471273

by Cardinal Health 200, LLC

Ref 8881471273Model MONOJECT Endodontic Needle-Sterile

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number063014000000000000001376G Basic UDI-DI 20192253037552UDI-DIDate22 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20192253037552 UDI-DI Date11 Aug 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Monoject
Generic Name
Dental irrigation/aspiration syringe
Device Name
MONOJECT Endodontic Needle-Sterile
Model / Ref / Catalog
8881471273, MONOJECT Endodontic Needle-Sterile
Description
Endodontic Needle 27 G x 1-1/4 in. (0.4 x 32 mm)
Primary DI / UDI-DI
20192253037552
Basic UDI-DI
063014000000000000001376G
Unit of Use DI
10192253037555
FDA Product Code
EIC
EMDN Code
A010602 Dental irrigation needles
GMDN Term
Dental irrigation/aspiration syringe
Device Class
Class I
Regulation Number
872.4565
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 27 Gauge
Length — 32 Millimeter

Other devices from Cardinal Health 200, LLC

See all devices from Cardinal Health 200, LLC →

Properties

  • Sterile
  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No