Identity
- Trade Name
- NAIL 18G EUDAMEDNAIL range FDA UDI
- Generic Name
- Needle guide, reusable FDA UDI
- Device Name
- Nails are used to guide linear instruments such as needles for application such as ultrasound biopsy guided procedure. The NAIL.18 can be used with needles from 17 to 20 Gauge. FDA UDI
- Model / Reference
- NAIL.18 EUDAMEDFDA UDINail EUDAMED
- Description
- Nails are used to guide linear instruments such as needles for application such as ultrasound biopsy guided procedure. The NAIL.18 can be used with needles from 17 to 20 Gauge. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03665134000158 EUDAMEDFDA UDI
- Basic UDI-DI
- 3665134Nail_01NJ EUDAMED
- 510(k) Number
- K171040 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z11049080 VARIOUS ULTRASOUND INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Needle guide, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Market of Registration
- France 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Needle guide, reusable
NAIL range by Koelis — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Koelis
Sources (2)
- FDA UDI 3e66acc4-160d-4b3b-974c-03c0991e9b87 35 fields · synced Jul 17, 2026
- EUDAMED 8c167b6f-0512-4fda-b35e-dce7b5b12596 61 fields · synced Jul 17, 2026