← Back to catalogue

GE Reusable Endocavity Needle Guide

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref H46721R

by Civco Medical Instruments Co., Inc.

Identity

Trade Name
GE 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 GE Healthcare IC9 transducers FDA UDI
Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with GE Healthcare 4DE7C, RIC5-9, and RIC6-12 transducers FDA UDI
Model / Reference
H46721R EUDAMEDFDA UDI
H48701MN FDA UDI
Description
Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with GE Healthcare IC9 transducers FDA UDI
Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with GE Healthcare 4DE7C, RIC5-9, and RIC6-12 transducers FDA UDI

Identifiers

Catalog Number
H48701MN FDA UDI
H46721R FDA UDI
Primary DI / UDI-DI
00841436114219 EUDAMEDFDA UDI
00841436111973 FDA 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 — 7.1 Inch FDA UDI
Width — 1.1 Inch FDA UDI
Length — 7.46 Inch FDA UDI
Width — 0.6 Inch FDA UDI

Category: Needle guide, reusable

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

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

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

Manufacturer

Manufacturer
Civco Medical Instruments Co., Inc.

Sources (3)

  • FDA UDI d47a5c7a-bf5c-4b3e-bda5-41c1c36abfcc 37 fields · synced Jul 13, 2026
  • FDA UDI 3ee656e2-9435-4de3-a9d0-e39e68b0c64b 37 fields · synced May 30, 2026
  • EUDAMED 8e0edc7f-0f04-47d0-941b-dc22cdafb233 61 fields · synced Jul 13, 2026