Identity
- Trade Name
- Optilite FDA UDI
- Generic Name
- Urogenital surgical laser system beam guide, single-use FDA UDI
- Device Name
- OptiLite Single Use Holmium Laser Fiber Use With Odyssey Holmium Laser Systems FDA UDI
- Model / Reference
- G48616 FDA UDI
- Description
- OptiLite Single Use Holmium Laser Fiber Use With Odyssey Holmium Laser Systems FDA UDI
Identifiers
- Catalog Number
- HLF-S365-CNV FDA UDI
- Primary DI / UDI-DI
- 00827002486164 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Urogenital 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Urogenital surgical laser system beam guide, single-use
Optilite by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Cook Incorporated
Sources (1)
- FDA UDI 1eeeb14a-488a-43a7-8161-ef5b35b1b0eb 36 fields · synced Jun 8, 2026