ASSURE® ID Insulin 1cc Safety Syringe

FDA UDI

Class II (US FDA UDI)

by Arkray Usa, Inc.

Identity

Trade Name: ASSURE® ID Insulin 1cc Safety Syringe FDA UDI
Generic Name: Metered-delivery hypodermic syringe/needle FDA UDI
Device Name: Sterile Safety Syringe FDA UDI
Model / Reference: 210291 FDA UDI
Description: Sterile Safety Syringe FDA UDI

Identifiers

Primary DI / UDI-DI: 00015482102913 FDA UDI
510(k) Number: K103011 FDA UDI
FDA Product Code: FMI FDA UDI
GMDN Term: Metered-delivery hypodermic syringe/needle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5570 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

Dimensions & Sizes

Size: Needle Gauge — 29 Gauge FDA UDI
Length — 0.5 Inch FDA UDI
Total Volume — 1 Milliliter FDA UDI

ASSURE® ID Insulin 1cc Safety Syringe by Arkray Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K103011 also covers:

UltiCare — ULTI MED, INC.
UltiCare — ULTI MED, INC.

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: Arkray Usa, Inc.

Sources (1)

FDA UDI 6e14eff8-fc0e-41a3-9e43-cc55594f2a38 37 fields · synced Jun 8, 2026