SOL-Guard Safety Needle

FDA UDI

Class II (US FDA UDI)

by Anhui Hongyu Wuzhou Medical Manufacturer Co Ltd

Identity

Trade Name: SOL-Guard Safety Needle FDA UDI
Generic Name: Hypodermic needle, single-use FDA UDI
Device Name: A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device. FDA UDI
Model / Reference: 21G x 1 1/2" FDA UDI
Description: A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device. FDA UDI

Identifiers

Catalog Number: SND480 FDA UDI
Primary DI / UDI-DI: 06958697603001 FDA UDI
510(k) Number: K190183 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

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

Category: Hypodermic needle, single-use

SOL-Guard Safety Needle by Anhui Hongyu Wuzhou Medical Manufacturer Co Ltd — 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

Cleared under the same submission

K190183 also covers:

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

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Manufacturer

Manufacturer: Anhui Hongyu Wuzhou Medical Manufacturer Co Ltd

Sources (1)

FDA UDI 9079e1f6-150f-4187-969c-84c03918084d 35 fields · synced May 30, 2026