SOL-CARE™ Safety Syringe with Fixed Needle

FDA UDI

Class II (US FDA UDI)

by Sol-Millennium Medical, Inc.

Identity

Trade Name: SOL-CARE™ Safety Syringe with Fixed Needle FDA UDI
Generic Name: Metered-delivery hypodermic syringe/needle FDA UDI
Device Name: A sterile, single use, safety syringe with a fixed needle that is used to inject fluids into, or withdraw fluids from, the body. In addition, the device is also designed to aid in the prevention of needle stick injuries 0.5ml safety syringe with 23g x 3/8" needle FDA UDI
Model / Reference: 100023IM FDA UDI
Description: A sterile, single use, safety syringe with a fixed needle that is used to inject fluids into, or withdraw fluids from, the body. In addition, the device is also designed to aid in the prevention of needle stick injuries 0.5ml safety syringe with 23g x 3/8" needle FDA UDI

Identifiers

Primary DI / UDI-DI: 00818392014327 FDA UDI
FDA Product Code: MEG FDA UDI
GMDN Term: Metered-delivery hypodermic syringe/needle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5860 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: Total Volume — 0.5 Milliliter FDA UDI
Length — 10 Millimeter FDA UDI
Needle Gauge — 23 Gauge FDA UDI

Category: Metered-delivery hypodermic syringe/needle

SOL-CARE™ Safety Syringe with Fixed Needle by Sol-Millennium Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Sol-Millennium Medical, Inc.

Sources (1)

FDA UDI 22b760ae-57f7-44b6-8598-8dd72ffd2c3f 35 fields · synced Jun 9, 2026