Intera

FDA UDI

Class III (US FDA UDI)

by Intera Oncology

Identity

Trade Name: INTERA FDA UDI
Generic Name: Hypodermic needle, single-use FDA UDI
Device Name: Special Bolus Needle for use with Intera 3000 Hepatic Artery Infusion Pump Straight Length 2" (5 cm) FDA UDI
Model / Reference: AP-04032-5 FDA UDI
Description: Special Bolus Needle for use with Intera 3000 Hepatic Artery Infusion Pump Straight Length 2" (5 cm) FDA UDI

Identifiers

Catalog Number: AP040325 FDA UDI
Primary DI / UDI-DI: 00850014110055 FDA UDI
FDA Product Code: LKK FDA UDI
GMDN Term: Hypodermic needle, single-use FDA UDI

Classification

Device Class: Class III 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: Needle Gauge — 20 Gauge FDA UDI
Length — 2 Inch FDA UDI

Category: Hypodermic needle, single-use

Intera by Intera Oncology — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hypodermic needle, single-use.

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Yeso med — WUXI YUSHOU MEDICAL APPLIANCES CO., LTD. · Class II
EasyTouch — MHC Medical Products · Class II
STERiJECT TM — TSK LABORATORY, JAPAN · Class II
Comfort EZ Pro — S.D.I. USA, 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 III	Pending data

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Manufacturer

Manufacturer: Intera Oncology

Sources (1)

FDA UDI f43a604b-5cc2-44fd-9104-b2744ad6ae4a 36 fields · synced May 30, 2026