Invivo

FDA UDI

Class II (US FDA UDI)

by Philips DS North America LLC

Identity

Trade Name: Invivo FDA UDI
Generic Name: Body aspiration needle, single-use FDA UDI
Device Name: Puncture Needle FDA UDI
Model / Reference: 98960320307 FDA UDI
Description: Puncture Needle FDA UDI

Identifiers

Primary DI / UDI-DI: 00884838072695 FDA UDI
FDA Product Code: KNW FDA UDI
GMDN Term: Body aspiration needle, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1075 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

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

Sterilization Method

Radiation Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 150 Millimeter FDA UDI
Needle Gauge — 16 Gauge FDA UDI

Category: Body aspiration needle, single-use

Invivo by Philips DS North America LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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COMPLETE-CHIBA MR — STERYLAB SRL · Class II
BIOMOL — H.S. HOSPITAL SERVICE SPA · Class II
MReye — COOK INCORPORATED · Class II
CHIBA SONO — Pajunk GmbH Medizintechnologie · 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: Philips DS North America LLC

Sources (1)

FDA UDI a42b4afd-3ae2-4a06-85a5-7a3dac2e5017 36 fields · synced Jun 8, 2026