← Back to catalogue

Sterile disposable guide

EUDAMEDFDA UDIFDA 510(k)

Class I (EU MDR)

Ref KDNG00Model Sterile disposable guide

by Koelis

Identity

Trade Name
Sterile disposable guide EUDAMED
Disposable guide for 3D endocavity end-fire FDA UDI
Generic Name
Needle guide, single-use FDA UDI
Device Name
Sterile disposable guide EUDAMED
The product concerned is a plastic guide designed to be plugged on an endocavity ultrasound probe, to guide a linear instrument through transrectal access. The guide is composed of 2 parts welded together to have: • a channel to receive and guide the linear instrument • a clip to allow the guide stability on the transducer • 2 pins for attachment in the notches of the probe • a guide cone to introduce easily the needle into the tube FDA UDI
Model / Reference
Sterile disposable guide EUDAMED
KDNG00 EUDAMEDFDA UDI
Description
The product concerned is a plastic guide designed to be plugged on an endocavity ultrasound probe, to guide a linear instrument through transrectal access. The guide is composed of 2 parts welded together to have: • a channel to receive and guide the linear instrument • a clip to allow the guide stability on the transducer • 2 pins for attachment in the notches of the probe • a guide cone to introduce easily the needle into the tube FDA UDI

Identifiers

Primary DI / UDI-DI
03665134000004 EUDAMED
03665134000011 FDA UDI
Basic UDI-DI
3665134GuidesUU_01MR EUDAMED
510(k) Number
K180970 FDA UDI
FDA Product Code
ITX FDA UDI
EMDN Code
Z11040185 ULTRASOUND SCANNERS - CONSUMABLES EUDAMED
GMDN Term
Needle guide, single-use FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
Market of Registration
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

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

No

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Sterile disposable guide by Koelis — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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

Manufacturer

Manufacturer
Koelis
EUDAMED SRN
FR-MF-000000830

Sources (3)

  • EUDAMED 01b09ad5-6fb4-4f79-be90-b6a7835029de 61 fields · synced Jul 17, 2026
  • FDA UDI 79218aab-3004-4a3c-8afe-026186bd515b 36 fields · synced May 30, 2026
  • FDA 510(k) K180970 1 fields · synced May 18, 2026