Identity
- Trade Name
- COMPLETE SE BILIARY FDA UDI
- Generic Name
- Bare-metal biliary stent FDA UDI
- Device Name
- STENT SC580L COMPLETE SE LONG US 3L G FDA UDI
- Model / Reference
- SC580L FDA UDI
- Description
- STENT SC580L COMPLETE SE LONG US 3L G FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994542038 FDA UDI
- 510(k) Number
- K062264 FDA UDI
- FDA Product Code
- FGE FDA UDI
- GMDN Term
- Bare-metal biliary stent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5010 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 80.0 Millimeter FDA UDI
Complete Se Biliary by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K062264 also covers:
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
- Medtronic, Inc.
Sources (1)
- FDA UDI 2ca17530-a966-455d-a861-6d359ce022fc 38 fields · synced May 31, 2026