Integrated Needle Guide

FDA UDI

Class II (US FDA UDI)

by Civco Medical Instruments Co., Inc.

Identity

Trade Name: Integrated Needle Guide FDA UDI
Generic Name: Needle guide, single-use FDA UDI
Device Name: Sterile needle guide with (17.8 x 147cm) telescopically-folded CIV-Flex™ cover for use with Canon Medical Systems PVI-450BPX (i8CXP1) transducers FDA UDI
Model / Reference: 680-172, 680-172-5 FDA UDI
Description: Sterile needle guide with (17.8 x 147cm) telescopically-folded CIV-Flex™ cover for use with Canon Medical Systems PVI-450BPX (i8CXP1) transducers FDA UDI

Identifiers

Catalog Number: 680-172, 680-172-5 FDA UDI
Primary DI / UDI-DI: 10841436118702 FDA UDI
FDA Product Code: IYO 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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Needle guide, single-use

Integrated Needle Guide by Civco Medical Instruments Co., Inc. — 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: Civco Medical Instruments Co., Inc.

Sources (1)

FDA UDI be0fd04c-06bd-4d56-bab8-98245c57ac3b 36 fields · synced Jun 8, 2026