Identity
- Trade Name
- IOL Manipulator - Lester FDA UDI
- Generic Name
- Open-surgery dissector FDA UDI
- Device Name
- Positioning of intraocular lens. Angled 10 mm from tip. Tip diameter 0.25 mm. FDA UDI
- Model / Reference
- 6801 FDA UDI
- Description
- Positioning of intraocular lens. Angled 10 mm from tip. Tip diameter 0.25 mm. FDA UDI
Identifiers
- Catalog Number
- 6801 FDA UDI
- Primary DI / UDI-DI
- 00813465011135 FDA UDI
- FDA Product Code
- KYB FDA UDI
- GMDN Term
- Open-surgery dissector FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
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
Yes
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
- Length — 22 Millimeter FDA UDIOuter Diameter — 0.25 Millimeter FDA UDI
Category: Open-surgery dissector
IOL Manipulator - Lester by Hurricane Medical — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Hurricane Medical
Sources (1)
- FDA UDI 82deb134-c507-4b6c-9ccc-6808e6ee1246 35 fields · synced Jun 8, 2026