SOL-M™ U-100 Insulin Syringe with Fixed Needle

FDA UDI

Class II (US FDA UDI)

by Sol-Millennium Medical, Inc.

Identity

Trade Name: SOL-M™ U-100 Insulin Syringe with Fixed Needle FDA UDI
Generic Name: Insulin syringe/needle, basic FDA UDI
Device Name: Intended for medical purposes for the manual aspiration of insulin (U-100 Insulin Only), and for the injection of insulin into parts of the body below the surface skin. FDA UDI
Model / Reference: 16130516 FDA UDI
Description: Intended for medical purposes for the manual aspiration of insulin (U-100 Insulin Only), and for the injection of insulin into parts of the body below the surface skin. FDA UDI

Identifiers

Primary DI / UDI-DI: 00818392010909 FDA UDI
FDA Product Code: FMF FDA UDI
GMDN Term: Insulin syringe/needle, basic 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

Yes

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: Length — 8 Millimeter FDA UDI
Total Volume — 1 Milliliter FDA UDI
Needle Gauge — 30 Gauge FDA UDI

Category: Insulin syringe/needle, basic

SOL-M™ U-100 Insulin 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 1cb9834b-130d-4c7f-b406-5be51467b363 35 fields · synced Jun 9, 2026