Identity
- Trade Name
- SpyGlass™ Discover FDA UDI
- Generic Name
- Endoscopic video image processing/light source system FDA UDI
- Device Name
- Digital Controller FDA UDI
- Model / Reference
- M0054295R0 FDA UDI
- Description
- Digital Controller FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729998754 FDA UDI
- FDA Product Code
- NTN FDA UDI
- GMDN Term
- Endoscopic video image processing/light source system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscopic video image processing/light source system
SpyGlass™ Discover by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific
Sources (1)
- FDA UDI 48e510e4-5d32-43b8-8308-a7c43ad79fcd 33 fields · synced Jun 8, 2026