Identity
- Trade Name
- SpyGlass™ Discover FDA UDI
- Generic Name
- Cholangiography catheter FDA UDI
- Device Name
- Imager™ II IOC Catheter FDA UDI
- Model / Reference
- M00542980 FDA UDI
- Description
- Imager™ II IOC Catheter FDA UDI
Identifiers
- Catalog Number
- M00542980 FDA UDI
- Primary DI / UDI-DI
- 00191506005221 FDA UDI
- FDA Product Code
- GBZ FDA UDI
- GMDN Term
- Cholangiography catheter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Length — 65 Centimeter FDA UDICatheter Gauge — 5 French FDA UDI
Category: Cholangiography catheter
SpyGlass™ Discover by Boston Scientific — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cholangiography catheter.
- AeroStat® — APPLIED MEDICAL RESOURCES CORP. · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific
Sources (1)
- FDA UDI 8e9b5b13-b28c-4d9e-b59a-b0013c51d286 35 fields · synced Jun 6, 2026