Identity
- Trade Name
- Auryon Atherectomy Catheter FDA UDI
- Generic Name
- Atherectomy laser system beam guide-catheter, peripheral FDA UDI
- Device Name
- Catheter Eximo Atherectomy 1.5mm - Hydrophilic Coated FDA UDI
- Model / Reference
- EXM-4001-H000 FDA UDI
- Description
- Catheter Eximo Atherectomy 1.5mm - Hydrophilic Coated FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290017590141 FDA UDI
- FDA Product Code
- MCW FDA UDI
- GMDN Term
- Atherectomy laser system beam guide-catheter, peripheral FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4875 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
No
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
- Outer Diameter — 1.5 Millimeter FDA UDILength — 150 Centimeter FDA UDILumen/Inner Diameter — 0.014 Inch FDA UDI
Category: Atherectomy laser system beam guide-catheter, peripheral
Auryon Atherectomy Catheter by Eximo Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Atherectomy laser system beam guide-catheter, peripheral.
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- NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter — NORTHEAST SCIENTIFIC, INC. · Class II
- Turbo-Power™ — Spectranetics Corporation · Class II
- NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter — NORTHEAST SCIENTIFIC, INC. · Class II
- Turbo-Elite™ — Spectranetics Corporation · Class II
- Turbo-Power™ — Spectranetics Corporation · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Eximo Medical Ltd
Sources (1)
- FDA UDI 90631b81-72d0-43d5-aac5-2f93a70985b1 36 fields · synced May 30, 2026