Identity
- Trade Name
- LithoVue Empower™ EUDAMEDFDA UDI
- Generic Name
- Surgical instrument handle grip FDA UDI
- Device Name
- LithoVue Empower Retrieval Deployment Device EUDAMEDRetrieval Deployment Device FDA UDI
- Model / Reference
- M0067919900 EUDAMEDFDA UDI
- Description
- Retrieval Deployment Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729977612 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000078N5 EUDAMED
- FDA Product Code
- FFY FDA UDI
- EMDN Code
- Z12020799 GENITOURINARY ENDOSCOPY INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Surgical instrument handle grip FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.1500 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
Yes
FDA UDI
LithoVue Empower™ by Boston Scientific Corporation — Class I — 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 | 01915060000000000000078N5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 56b6e3f9-b82d-41a5-9b45-8d4236d56039 61 fields · synced Jun 18, 2026
- FDA UDI a540cb80-6b2a-4198-8c3d-066aa90cd8ab 33 fields · synced May 30, 2026