Identity
- Trade Name
- 0.9 mm OTW B-Laser™ catheter FDA UDI
- Generic Name
- Atherectomy laser system beam guide-catheter, peripheral FDA UDI
- Device Name
- 0.9 mm OTW B-Laser™ catheter For Infra Inguinal Atherectomy FDA UDI
- Model / Reference
- EXM-4002-0000 FDA UDI
- Description
- 0.9 mm OTW B-Laser™ catheter For Infra Inguinal Atherectomy FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290017590011 FDA UDI
- 510(k) Number
- K181642 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
- 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
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
0.9 mm OTW B-Laser™ catheter by Eximo Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K181642 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
- Eximo Medical Ltd
Sources (1)
- FDA UDI 82ef8446-a63e-495d-acf5-5b0c528efe7c 36 fields · synced Jun 1, 2026