SOL-CARE™ Insulin Syringe w/Fixed Needle

FDA UDI

Class II (US FDA UDI)

by Sol-Millennium Medical, Inc.

Identity

Trade Name: SOL-CARE™ Insulin Syringe w/Fixed Needle FDA UDI
Generic Name: Insulin syringe/needle, safety FDA UDI
Device Name: SOL-CARE 1ml Insulin Syringe w/Fixed Needle 31G*5/16 (U-100 Insulin Only) FDA UDI
Model / Reference: 100091IM FDA UDI
Description: SOL-CARE 1ml Insulin Syringe w/Fixed Needle 31G*5/16 (U-100 Insulin Only) FDA UDI

Identifiers

Primary DI / UDI-DI: 00818392013924 FDA UDI
FDA Product Code: MEG FDA UDI
GMDN Term: Insulin syringe/needle, safety 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 — 1 Milliliter FDA UDI
Needle Gauge — 31 Gauge FDA UDI
Length — 8 Millimeter FDA UDI

Category: Insulin syringe/needle, safety

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

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Also classified as Insulin syringe/needle, safety.

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ONE-CARE Safety Pen Needles 30G x 8mm, Yellow, — MediVena, LLC · Class II
Endure — ENDURE INDUSTRIES, INC. · Class II
McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
Disposable Insulin Syringe — Berpu Medical Technology Co., Ltd · Class II
RELI — MYCO MEDICAL SUPPLIES 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

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Manufacturer

Manufacturer: Sol-Millennium Medical, Inc.

Sources (1)

FDA UDI 39c4e8f9-1cb5-4ee6-a1d2-d30e5190d70b 35 fields · synced Jun 9, 2026