Identity
- Trade Name
- Flexiva Pulse FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, single-use FDA UDI
- Device Name
- Flexiva Pulse and Flexiva Pulse TracTip laser fibers are high power single-use fiber FDA UDI
- Model / Reference
- M006L8405930 FDA UDI
- Description
- Flexiva Pulse and Flexiva Pulse TracTip laser fibers are high power single-use fiber FDA UDI
Identifiers
- Catalog Number
- M006L8405930 FDA UDI
- Primary DI / UDI-DI
- 08714729978596 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical laser system beam guide, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 2.6 Meter FDA UDI
Category: General/multiple surgical laser system beam guide, single-use
Flexiva Pulse by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- neoLaser Laser Surgery Fiber — G.N.S Neolaser , Ltd. · 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
- Boston Scientific
Sources (1)
- FDA UDI e2dfba44-e7ee-4b8c-bc29-6aab1ae9a87d 35 fields · synced May 30, 2026