Identity
- Trade Name
- Aesculap EUDAMEDFDA UDI
- Generic Name
- Vascular graft tunneller FDA UDI
- Device Name
- Tunneler EUDAMEDJENKNER TUNNELER W/CONI-TIP 500X12MM FDA UDI
- Model / Reference
- FC005R EUDAMEDFDA UDI
- Description
- JENKNER TUNNELER W/CONI-TIP 500X12MM FDA UDI
Identifiers
- Catalog Number
- FC005R FDA UDI
- Primary DI / UDI-DI
- 04038653065097 EUDAMEDFDA UDI
- Basic UDI-DI
- 4039239000001109ZS EUDAMED
- FDA Product Code
- FZX FDA UDI
- EMDN Code
- L070805 VASCULAR TUNNELLERS, REUSABLE EUDAMED
- GMDN Term
- Vascular graft tunneller FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Vascular graft tunneller
Aesculap by Aesculap AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 4039239000001109ZS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED 37ff1022-863b-4ca1-b6d8-9c0294ac9eee 61 fields · synced Jun 1, 2026
- FDA UDI e78c2f95-4d04-41bd-9d5c-471e9e38c9c6 35 fields · synced May 30, 2026