Assure® ID PRO Safety Pen Needles 30gx5mm 100's

FDA UDI

Class II (US FDA UDI)

by Arkray Usa, Inc.

Identity

Trade Name: Assure® ID PRO Safety Pen Needles 30gx5mm 100's FDA UDI
Generic Name: Autoinjector needle FDA UDI
Device Name: Assure ID PRO Safety Pen Needles are disposable, sterile needles intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawal from the body, the two safety shields on the patient-end and the pen connection-end automatically cover the needle and lock to minimize the risk of accidental needle sticks. FDA UDI
Model / Reference: 276530 FDA UDI
Description: Assure ID PRO Safety Pen Needles are disposable, sterile needles intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawal from the body, the two safety shields on the patient-end and the pen connection-end automatically cover the needle and lock to minimize the risk of accidental needle sticks. FDA UDI

Identifiers

Primary DI / UDI-DI: 00015482276539 FDA UDI
FDA Product Code: FMI FDA UDI
GMDN Term: Autoinjector needle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5570 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

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Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 30 Gauge FDA UDI
Length — 5 Millimeter FDA UDI

Category: Autoinjector needle

Assure® ID PRO Safety Pen Needles 30gx5mm 100's by Arkray Usa, 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: Arkray Usa, Inc.

Sources (1)

FDA UDI 0080d72d-8d84-4b84-9400-a93e44c36a32 35 fields · synced May 30, 2026