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 Mindray 3C5A, 3C5, 3C5s, 3C5P Ultrasound Transducers and Innofine Disposable Needle Guides DGC-01,DGC-0101 or DGC-0102. FDA UDI
Model / Reference: JSP-006 FDA UDI
Description: Reusable Needle Guides for use with Mindray 3C5A, 3C5, 3C5s, 3C5P Ultrasound Transducers and Innofine Disposable Needle Guides DGC-01,DGC-0101 or DGC-0102. FDA UDI

Identifiers

Catalog Number: 10305 FDA UDI
Primary DI / UDI-DI: 06971554723056 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Needle guide, reusable

A comprehensive directory of medical devices, featuring the InnoFine Biopsy Needle Guide Kit. This reusable device is designed for precision and safety in various clinical settings.

Similar devices

Also classified as Needle guide, reusable.

Redon guide needle — Spiggle & Theis Medizintechnik GmbH · Class I
EZU-PA5O-14 — FUJIFILM Corporation · Class II
Duckworth & Kent — DUCKWORTH AND KENT LIMITED · Class I
MP-2794-G16 — FUJIFILM Corporation · Class II
EV29L Non-Sterile Reusable PrecisionPoint Adapter — Exact Imaging · Class II
Endocavity Biopsy Starter Kit — PROTEK MEDICAL PRODUCTS, INC.
Gimmi — Gimmi GmbH · Class I
MP-2785-G23 — FUJIFILM Corporation · 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: JingFang Precision Medical Device(Shenzhen) Co., Ltd.

Sources (1)

FDA UDI 7d919245-f8a6-48c8-8ca7-b3c77dfd1603 34 fields · synced Jul 22, 2026