Identity
- Trade Name
- TLA Introducer Needle and Sheath FDA UDI
- Generic Name
- Nephrostomy catheter introduction needle FDA UDI
- Device Name
- UROLOGY INTRODUCERS EUDAMEDIntroducer Needle Set FDA UDI
- Model / Reference
- M0067001200 EUDAMEDFDA UDI
- Description
- Introducer Needle Set FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729005209 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000602N2 EUDAMED
- FDA Product Code
- GBO FDA UDI
- EMDN Code
- U040299 DEVICES FOR PERCUTANEOUS NEPHROSTOMY - OTHER EUDAMED
- GMDN Term
- Nephrostomy catheter introduction needle 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
Yes
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
Urology Introducers 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 | 01915060000000000000602N2 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific Corporation
- EUDAMED SRN
- US-MF-000004702
- Authorised Representative
- Boston Scientific Limited IE-AR-000003840
Sources (2)
- EUDAMED 607f91bc-5648-41a9-9234-5e22c4ccb159 61 fields · synced Jul 19, 2026
- FDA UDI 4fc77bad-d073-4d6b-a07d-b9b579f7b21f 34 fields · synced May 30, 2026