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Pipeline Access System
EUDAMEDFDA UDIClass I (EU MDR)
Ref 288205031Model Pipeline Access System Instruments Bone Spoons and Curettes
Identity
- Trade Name
- PIPELINE ACCESS SYSTEM EUDAMEDPIPELINE FDA UDI
- Generic Name
- Orthopaedic joint/limb rongeur FDA UDI
- Device Name
- Pipeline Access Rongeur Curette Pituitary EUDAMEDPIPELINE ACCESS SYSTEM 40 DEGREES KERRISON RONGEUR 4mm FDA UDI
- Model / Reference
- Pipeline Access System Instruments Bone Spoons and Curettes EUDAMED288205031 EUDAMEDFDA UDI
- Description
- PIPELINE ACCESS SYSTEM 40 DEGREES KERRISON RONGEUR 4mm FDA UDI
Identifiers
- Catalog Number
- 288205031 FDA UDI
- Primary DI / UDI-DI
- 10705034220390 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705034a000465U EUDAMED
- Direct Marketing DI
- 10705034220390 EUDAMED
- FDA Product Code
- HTX FDA UDI
- EMDN Code
- L0901 ORTHOPAEDIC SURGERY SPOONS AND CURETTES, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic joint/limb rongeur FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Belgium 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: Bone curette, reusable
Pipeline Access System by Medos International Sarl — 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 | 0705034a000465U | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medos International SARL
- EUDAMED SRN
- CH-MF-000014268
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (2)
- EUDAMED 0a4e9bfc-cac7-4d71-be08-7bd8b3a4e61f 61 fields · synced Jul 9, 2026
- FDA UDI 02df24ad-74ba-401d-9f22-23105d8f6d18 35 fields · synced May 29, 2026