Identity
- Trade Name
- NAIL 14G EUDAMEDNAIL range FDA UDI
- Generic Name
- Needle guide, reusable FDA UDI
- Device Name
- the device Nail.14 is used to guide linear instruments such as needle during, for example, ultrasound guided biopsy procedure. The nail.14 is compatible with needles from 14 to 16 gauge. The device is reusable but must be sterilized before use. The device is not provided in sterile condition. FDA UDI
- Model / Reference
- Nail EUDAMEDNAIL.14 EUDAMEDFDA UDI
- Description
- the device Nail.14 is used to guide linear instruments such as needle during, for example, ultrasound guided biopsy procedure. The nail.14 is compatible with needles from 14 to 16 gauge. The device is reusable but must be sterilized before use. The device is not provided in sterile condition. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03665134000165 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
Nail 14g by Koelis — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 3665134Nail_01NJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Koelis
- EUDAMED SRN
- FR-MF-000000830
Sources (2)
- EUDAMED 0630da84-3348-4e40-a232-7c274209620b 61 fields · synced Jul 22, 2026
- FDA UDI 92598f13-389e-4f68-8d74-75f7f7579cd5 35 fields · synced May 30, 2026