Lin Lead 14g

FDA UDI

Class II (US FDA UDI)

by Koelis

Identity

Trade Name: LIN LEAD 14G FDA UDI
Generic Name: Needle guide, reusable FDA UDI
Device Name: Needle guide compatible with the linear 2D ultrasound probe. It is made of two parts. One part is fixed on the ultrasound probe. The other removable part is perforated and inserted in the first part to guide the needle. The device is designed to guide needles with a diameter from 14G to 16G. The guides are reusable after appropriate procedure. They are not delivered in sterile condition FDA UDI
Model / Reference: KRNG.LN.14 FDA UDI
Description: Needle guide compatible with the linear 2D ultrasound probe. It is made of two parts. One part is fixed on the ultrasound probe. The other removable part is perforated and inserted in the first part to guide the needle. The device is designed to guide needles with a diameter from 14G to 16G. The guides are reusable after appropriate procedure. They are not delivered in sterile condition FDA UDI

Identifiers

Primary DI / UDI-DI: 03665134000318 FDA UDI
510(k) Number: K171040 FDA UDI
FDA Product Code: ITX FDA UDI
GMDN Term: Needle guide, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1570 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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Needle guide, reusable

Lin Lead 14g by Koelis — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Needle guide, reusable.

Redon guide needle — Spiggle & Theis Medizintechnik GmbH · Class I
InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
EZU-PA5O-14 — FUJIFILM Corporation · Class II
InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
Duckworth & Kent — DUCKWORTH AND KENT LIMITED · Class I
MP-2794-G16 — FUJIFILM Corporation · Class II
InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II

Cleared under the same submission

K171040 also covers:

CON LEAD 14G — KOELIS
CON LEAD 18G — KOELIS
LIN LEAD 18G — KOELIS
NAIL range — KOELIS
Steady Pro — KOELIS
Steady Pro — KOELIS
transP - Reusable Guid Perine Nail 14G — KOELIS
transP - Reusable Guid Perine Nail 18G — KOELIS

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

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

Manufacturer

Manufacturer: Koelis

Sources (1)

FDA UDI 3cc0344d-d438-43e9-917e-26c158a90dc0 35 fields · synced Jun 1, 2026