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Monoject

FDA UDI

Class I (US FDA UDI)

by Cardinalhealth

Identity

Trade Name
Monoject FDA UDI
Generic Name
Dental syringe needle, single-use FDA UDI
Device Name
Dental Needle,Plastic Hub,25 G Short FDA UDI
Model / Reference
8881400041 FDA UDI
Description
Dental Needle,Plastic Hub,25 G Short FDA UDI

Identifiers

Catalog Number
8881400041 FDA UDI
Primary DI / UDI-DI
10884521002531 FDA UDI
FDA Product Code
DZM FDA UDI
GMDN Term
Dental syringe needle, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4730 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 0.75 Inch FDA UDI

Category: Dental syringe needle, single-use

Monoject by Cardinalhealth — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental syringe needle, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardinalhealth

Sources (1)

  • FDA UDI c5ca1621-a97d-4f19-9426-c423acff05ff 37 fields · synced Jun 1, 2026