Identity
- Trade Name
- Furlow EUDAMEDFDA UDI
- Generic Name
- Penile prosthesis implantation instrument FDA UDI
- Device Name
- Furlow Disposable Insertion Tool EUDAMEDDisposable Insertion Tool FDA UDI
- Model / Reference
- M00635400020 EUDAMEDFDA UDI
- Description
- Disposable Insertion Tool FDA UDI
Identifiers
- Catalog Number
- M00635400020 FDA UDI
- Primary DI / UDI-DI
- 00191506022181 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000497NV EUDAMED
- FDA Product Code
- QGA FDA UDI
- EMDN Code
- U1299 SINGLE-USE UROGENITAL INSTRUMENTATION (NON-ENDOSCOPIC) - OTHER EUDAMED
- GMDN Term
- Penile prosthesis implantation instrument FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 876.3500 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
Furlow 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 | 01915060000000000000497NV | 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 5e41cf3e-134b-4223-9cef-570862a9e637 61 fields · synced Jun 19, 2026
- FDA UDI 309e2221-97d4-4d4a-89fe-3a2051e1e64d 34 fields · synced May 30, 2026