GE Reusable Endocavity Needle Guide

FDA UDI

Class II (US FDA UDI)

by Civco Medical Instruments Co., Inc.

Identity

Trade Name: GE Reusable Endocavity 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 GE Healthcare IC9 transducers FDA UDI
Model / Reference: 5776036 FDA UDI
Description: Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with GE Healthcare IC9 transducers FDA UDI

Identifiers

Catalog Number: 5776036 FDA UDI
Primary DI / UDI-DI: 00841436113700 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: Width — 1.1 Inch FDA UDI
Length — 7.1 Inch FDA UDI

Category: Needle guide, reusable

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

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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

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Manufacturer

Manufacturer: Civco Medical Instruments Co., Inc.

Sources (1)

FDA UDI f4557da9-bc54-4c51-ad7e-b9ab27c2e8f9 37 fields · synced Jun 6, 2026