iNod™ Ultrasound Guided Biopsy Ne

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name: iNod™ Ultrasound Guided Biopsy Ne FDA UDI
Generic Name: Body aspiration needle, single-use FDA UDI
Device Name: Biopsy Needle FDA UDI
Model / Reference: M00502060 FDA UDI
Description: Biopsy Needle FDA UDI

Identifiers

Catalog Number: M00502060 FDA UDI
Primary DI / UDI-DI: 00191506020729 FDA UDI
FDA Product Code: ITX FDA UDI
EOQ FDA UDI
GMDN Term: Body aspiration needle, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1570 FDA UDI
874.4680 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

Category: Body aspiration needle, single-use Oesophageal ultrasound imaging transducer, single-use

iNod™ Ultrasound Guided Biopsy Ne by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Body aspiration needle, single-use.

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Invivo — Philips DS North America LLC · Class II
BIOMOL — H.S. HOSPITAL SERVICE SPA · Class II
MReye — COOK INCORPORATED · 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: Boston Scientific

Sources (1)

FDA UDI 499ef88b-f68b-469e-8b35-ad9db9507dfb 34 fields · synced Jun 1, 2026