Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Multi-purpose percutaneous abdominothoracic drainage catheter FDA UDI
- Device Name
- Renal Dilators & Renal Sheath EUDAMEDAmplatz Type Renal Dilator FDA UDI
- Model / Reference
- M0062601010 EUDAMEDFDA UDI
- Description
- Amplatz Type Renal Dilator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729005438 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000516N8 EUDAMED
- FDA Product Code
- GCC FDA UDI
- EMDN Code
- U03010101 AMPLATZ CANNULAS FOR URINARY DILATION EUDAMED
- GMDN Term
- Multi-purpose percutaneous abdominothoracic drainage catheter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4200 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Renal Dilators & Renal Sheath by Boston Scientific Corporation — Class IIa — 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 | 01915060000000000000516N8 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Boston Scientific Corporation
- EUDAMED SRN
- US-MF-000004702
- Authorised Representative
- Boston Scientific Limited IE-AR-000003840
Sources (2)
- EUDAMED ef0c404b-b65c-4f72-b0fc-c57bda64dd10 61 fields · synced Aug 4, 2026
- FDA UDI df4fbe9f-ac58-4dcb-ac64-bfef6138b293 34 fields · synced May 30, 2026