Comfort EZ

FDA UDI

Class II (US FDA UDI)

by S.d.i. Usa, Inc.

Identity

Trade Name: Comfort EZ FDA UDI
Generic Name: Insulin syringe/needle, basic FDA UDI
Device Name: Insulin Syringe - 100 count FDA UDI
Model / Reference: i31156 FDA UDI
Description: Insulin Syringe - 100 count FDA UDI

Identifiers

Catalog Number: 50002-0860-19 FDA UDI
Primary DI / UDI-DI: 00850002860191 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

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: Needle Gauge — 31 Gauge FDA UDI
Length — 8 Millimeter FDA UDI
Total Volume — 1 Milliliter FDA UDI

Category: Insulin syringe/needle, basic

Comfort EZ by S.d.i. Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Ultra-Care Insulin Syringe 30G 5/16" 0.5 CC 100 Ct — ARISE MEDICAL LLC · 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: S.d.i. Usa, Inc.

Sources (1)

FDA UDI 6431c535-b0ca-45ed-924c-cc22ce5590d0 35 fields · synced Jun 6, 2026