Needle Guide

FDA UDI

Class II (US FDA UDI)

by Civco Medical Instruments Co., Inc.

Identity

Trade Name: Needle Guide FDA UDI
Generic Name: Needle guide, reusable FDA UDI
Device Name: Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with ZONARE E9-4 transducer FDA UDI
Model / Reference: 698-002 FDA UDI
Description: Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with ZONARE E9-4 transducer FDA UDI

Identifiers

Catalog Number: 698-002 FDA UDI
Primary DI / UDI-DI: 00841436107914 FDA UDI
510(k) Number: K875128 FDA UDI
K875240 FDA UDI
FDA Product Code: IYO 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

Yes

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Height — 1.4 Inch FDA UDI
Length — 5.7 Inch FDA UDI

Category: Needle guide, reusable

Needle Guide by Civco Medical Instruments Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Needle guide, reusable.

Redon guide needle — Spiggle & Theis Medizintechnik GmbH · Class I
InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
EZU-PA5O-14 — FUJIFILM Corporation · Class II
InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
Duckworth & Kent — DUCKWORTH AND KENT LIMITED · Class I
MP-2794-G16 — FUJIFILM Corporation · Class II
InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II

Cleared under the same submission

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Civco Medical Instruments Co., Inc.

Sources (1)

FDA UDI 627f7e05-c9c7-49e1-9ffc-2bdb4d2c1a72 37 fields · synced Jun 6, 2026