Identity
- Trade Name
- ELCA™ FDA UDI
- Generic Name
- Atherectomy laser system beam guide-catheter, coronary FDA UDI
- Device Name
- ELCA™ Coronary Laser Atherectomy Catheter FDA UDI
- Model / Reference
- 110-002 FDA UDI
- Description
- ELCA™ Coronary Laser Atherectomy Catheter FDA UDI
Identifiers
- Catalog Number
- 110-002 FDA UDI
- Primary DI / UDI-DI
- M2041100020 FDA UDI
- FDA Product Code
- LPC FDA UDI
- GMDN Term
- Atherectomy laser system beam guide-catheter, coronary FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.97 Millimeter FDA UDI
Elca™ by Spectranetics Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 III | Pending data |
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Manufacturer
- Manufacturer
- Spectranetics Corporation
Sources (1)
- FDA UDI 3544d72f-a635-4a69-a7a3-494bedd8db8d 38 fields · synced Jun 1, 2026