Introducer D2.5 mm, 115 mm, Trocar
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Introducer D2.5 mm, 115 mm, Trocar EUDAMEDIntroducer D2.5 mm, 115 mm, Trocar. FDA UDI
- Generic Name
- Percutaneous non-endoscopic instrument access cannula FDA UDI
- Device Name
- Introducer D2.5 mm, 115 mm, Trocar EUDAMEDConsists of Mandrel (FAC9000000-1) and Canuula (FAC9000000-2) FDA UDI
- Model / Reference
- FAC9000000 EUDAMEDFDA UDI
- Description
- Consists of Mandrel (FAC9000000-1) and Canuula (FAC9000000-2) FDA UDI
Identifiers
- Catalog Number
- FAC9000000 FDA UDI
- Primary DI / UDI-DI
- 07290015487115 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07290015487115 EUDAMED
- FDA Product Code
- GDF FDA UDI
- EMDN Code
- V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
- GMDN Term
- Percutaneous non-endoscopic instrument access cannula FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 2.5 Millimeter FDA UDIShaft Length — 115 Millimeter FDA UDI
Category: Surgical retractor/retraction system blade, single-use
Introducer D2.5 mm, 115 mm, Trocar by Icecure Medical Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical retractor/retraction system blade, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07290015487115 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- IceCure Medical Ltd.
- EUDAMED SRN
- IL-MF-000026406
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED bf9f16dc-17d6-414e-b562-ecd89c848295 61 fields · synced Jul 9, 2026
- FDA UDI e96ea06a-7827-4bdc-8584-0abdf0ae468f 37 fields · synced May 30, 2026