InnoFine

FDA UDI

Class II (US FDA UDI)

by JingFang Precision Medical Device(Shenzhen) Co., Ltd.

Identity

Trade Name: InnoFine FDA UDI
Generic Name: Needle guide, reusable FDA UDI
Device Name: Reusable Needle Guides for use with Canon PVF-641VT, PVM-651VT, PVN-661VT, PVQ-641V, PVT-661VT, PVG-630v; Siemens EC9-4(ACUSON S1000, S2000, S3000, Antares) Ultrasound Transducers FDA UDI
Model / Reference: JEM-018 FDA UDI
Description: Reusable Needle Guides for use with Canon PVF-641VT, PVM-651VT, PVN-661VT, PVQ-641V, PVT-661VT, PVG-630v; Siemens EC9-4(ACUSON S1000, S2000, S3000, Antares) Ultrasound Transducers FDA UDI

Identifiers

Primary DI / UDI-DI: 06971554720185 FDA UDI
FDA Product Code: OIJ FDA UDI
GMDN Term: Needle guide, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Needle guide, reusable

InnoFine by JingFang Precision Medical Device(Shenzhen) Co., Ltd. — 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: JingFang Precision Medical Device(Shenzhen) Co., Ltd.

Sources (1)

FDA UDI f3cd1635-0b8d-44e6-8061-01ef29aed32b 33 fields · synced May 30, 2026