← Back to catalogue
Perine Full Grid 18G
EUDAMEDFDA UDIClass I (EU MDR)
Ref KRNG.EL4.18Model Reusable PERINE guides
by Koelis
Identity
- Trade Name
- Perine Full Grid 18G EUDAMEDtransP - perine full grid 18G FDA UDI
- Generic Name
- Needle guide, reusable FDA UDI
- Device Name
- PERINE GRID 14G EUDAMEDThe guides from PERINE range are intended to guide a needle during ultrasound-guided intervention. 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
- Reusable PERINE guides EUDAMEDKRNG.EL4.18 EUDAMEDFDA UDI
- Description
- The guides from PERINE range are intended to guide a needle during ultrasound-guided intervention. 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
- 03665134000141 EUDAMED03665134000257 FDA UDI
- Basic UDI-DI
- 3665134PerineGrid_01BN EUDAMED
- Direct Marketing DI
- 03665134000141 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
Dimensions & Sizes
- Size
- Guidewire Diameter — 1.63 Millimeter FDA UDI
Perine Full Grid 18G 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 | 3665134PerineGrid_01BN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Koelis
- EUDAMED SRN
- FR-MF-000000830
Sources (2)
- EUDAMED 982c54cb-6624-4a33-bec6-3248f1d7fa02 61 fields · synced Sep 17, 2026
- FDA UDI c04e7c63-1aaa-4e76-8bf6-443eca2abda1 36 fields · synced May 30, 2026