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, single-use FDA UDI
Device Name: Disposable Needle Guides Kit for endocavity biopsy, contents: Needle guide use with Samsung 3D4-9, 3D4-9ES; Siemens 9VE3, EV9F3 ultrasound transducers; 20g gel; 5x30cm latex cover, rubber bands. FDA UDI
Model / Reference: DEK-035 FDA UDI
Description: Disposable Needle Guides Kit for endocavity biopsy, contents: Needle guide use with Samsung 3D4-9, 3D4-9ES; Siemens 9VE3, EV9F3 ultrasound transducers; 20g gel; 5x30cm latex cover, rubber bands. FDA UDI

Identifiers

Catalog Number: 11340 FDA UDI
Primary DI / UDI-DI: 06975122553403 FDA UDI
FDA Product Code: OIJ FDA UDI
GMDN Term: Needle guide, single-use 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Needle guide, single-use

InnoFine by JingFang Precision Medical Device(Shenzhen) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Needle guide, single-use.

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Sterile Disposable Endocavity Needle Guide — PROTEK MEDICAL PRODUCTS, INC. · Class II
Coaxial needle — Möller Medical GmbH · Class II
Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
Coaxial needle — Möller Medical GmbH · Class II
Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
Verza Guidance System Master Carton — CIVCO MEDICAL INSTRUMENTS CO., 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 II	Pending data

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Manufacturer

Manufacturer: JingFang Precision Medical Device(Shenzhen) Co., Ltd.

Sources (1)

FDA UDI 41c541de-b2c5-4637-a733-04611b2b56d3 36 fields · synced May 30, 2026