Monoject

FDA UDI

Class II (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name: Monoject FDA UDI
Generic Name: Hypodermic needle, single-use FDA UDI
Device Name: Hypodermic Safety Needle 18G x 1" (1.2 x 25 mm) FDA UDI
Model / Reference: 8881850810 FDA UDI
Description: Hypodermic Safety Needle 18G x 1" (1.2 x 25 mm) FDA UDI

Identifiers

Catalog Number: 8881850810 FDA UDI
Primary DI / UDI-DI: 10192253024906 FDA UDI
FDA Product Code: FMI FDA UDI
GMDN Term: Hypodermic needle, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5570 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 18 Gauge FDA UDI
Length — 1 Inch FDA UDI

Category: Hypodermic needle, single-use

Monoject by Cardinal Health 200, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hypodermic needle, single-use.

Monoject — Cardinalhealth · Class II
Pinpoint GT — Bard Access Systems, Inc. · Class II
Safety Needle — Jiangsu Micsafe Medical Technology Co., Ltd · Class IIa
Syringe w/Needle, Non-Toxic, 25G x 1", Luer Lock — Dynarex Corp. · Class II
Yeso med — WUXI YUSHOU MEDICAL APPLIANCES CO., LTD. · Class II
EasyTouch — MHC Medical Products · Class II
STERiJECT TM — TSK LABORATORY, JAPAN · Class II
Comfort EZ Pro — S.D.I. USA, INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Cardinal Health 200, LLC

Sources (1)

FDA UDI 30957def-457e-422f-8c75-0f228fd49e53 35 fields · synced Jun 8, 2026