transP - Reusable Guid Perine Nail 18G

FDA UDI

Class II (US FDA UDI)

by Koelis

Identity

Trade Name: transP - Reusable Guid Perine Nail 18G FDA UDI
Generic Name: Needle guide, reusable FDA UDI
Device Name: "PERINE range guides are made up of one part fixed on the ultrasound probe, which enables needle guiding. PERINE range guides guide needles of 14 to 20 gauges. The guiding aims to place the needle in the ultrasound image plane. The guides are reusable medical devices." FDA UDI
Model / Reference: KRNG.EL2.18 FDA UDI
Description: "PERINE range guides are made up of one part fixed on the ultrasound probe, which enables needle guiding. PERINE range guides guide needles of 14 to 20 gauges. The guiding aims to place the needle in the ultrasound image plane. The guides are reusable medical devices." FDA UDI

Identifiers

Primary DI / UDI-DI: 03665134000233 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

Dimensions & Sizes

Size: Guidewire Diameter — 1.63 Millimeter FDA UDI

Category: Needle guide, reusable

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

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Manufacturer

Manufacturer: Koelis

Sources (1)

FDA UDI 3c57987c-66e5-42e5-a8f1-6264a45ab7d5 36 fields · synced May 30, 2026