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Reusable Endocavity Needle Guide

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 657-066

by Civco Medical Instruments Co., Inc.

Identity

Trade Name
Reusable Endocavity Needle Guide EUDAMEDFDA UDI
Generic Name
Needle guide, reusable FDA UDI
Device Name
Endocavity Guidance (Reusable guide) EUDAMED
Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with Samsung Medison EV3-10B and V5-9 transducers FDA UDI
Model / Reference
657-066 EUDAMEDFDA UDI
Description
Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with Samsung Medison EV3-10B and V5-9 transducers FDA UDI

Identifiers

Catalog Number
657-066 FDA UDI
Primary DI / UDI-DI
00841436114318 EUDAMEDFDA UDI
Basic UDI-DI
0841436101TD102A3NG EUDAMED
Direct Marketing DI
20841436114084 EUDAMED
510(k) Number
K875128 FDA UDI
K875240 FDA UDI
FDA Product Code
IYO FDA UDI
EMDN Code
A018002 NEEDLE GUIDES EUDAMED
GMDN Term
Needle guide, reusable FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
892.1560 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 7.46 Inch FDA UDI
Width — 0.6 Inch FDA UDI

Category: Needle guide, reusable

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

Similar devices

Also classified as Needle guide, reusable.

Cleared under the same submission

K875128 also covers:

K875240 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Civco Medical Instruments Co., Inc.

Sources (2)

  • FDA UDI ca91cc56-a8d3-418c-a00c-8d19f2389c01 37 fields · synced Sep 18, 2026
  • EUDAMED b69947b0-e88c-42ee-8329-e1a9b039c83b 61 fields · synced Sep 18, 2026