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Perine Grid 18G
EUDAMEDFDA UDIClass I (EU MDR)
Ref KRNG.EL1.18Model Reusable PERINE guides
by Koelis
Identity
- Trade Name
- Perine Grid 18G EUDAMEDtransP - Reusable Guid Perine Grid 18G FDA UDI
- Generic Name
- Needle guide, reusable FDA UDI
- Device Name
- PERINE GRID 14G EUDAMEDPERINE 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.EL1.18 EUDAMEDFDA 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
- 03665134000110 EUDAMED03665134000226 FDA UDI
- Basic UDI-DI
- 3665134PerineGrid_01BN EUDAMED
- Direct Marketing DI
- 03665134000110 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 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 |
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Manufacturer
- Manufacturer
- Koelis
- EUDAMED SRN
- FR-MF-000000830
Sources (2)
- EUDAMED 128868b1-ba84-4fa7-9f1c-346ad33bbdca 61 fields · synced Jul 9, 2026
- FDA UDI 7994a8f8-05e4-4d2f-9ec0-5c06a3c128fe 36 fields · synced May 30, 2026