IOL Manipulator - Lester 6801

GUDID 10813465011132

Positioning of intraocular lens. Angled 10 mm from tip. Tip diameter 0.25 mm.

HURRICANE MEDICAL INC

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Primary Device ID10813465011132
NIH Device Record Key82deb134-c507-4b6c-9ccc-6808e6ee1246
Commercial Distribution StatusIn Commercial Distribution
Brand NameIOL Manipulator - Lester
Version Model Number6801
Catalog Number6801
Company DUNS093377724
Company NameHURRICANE MEDICAL INC
Device Count5
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length22 Millimeter
Outer Diameter0.25 Millimeter
Length22 Millimeter
Outer Diameter0.25 Millimeter
Length22 Millimeter
Outer Diameter0.25 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100813465011135 [Primary]
GS110813465011132 [Unit of Use]

FDA Product Code

KYBLens, Guide, Intraocular

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10813465011132]

Moist Heat or Steam Sterilization;Radiation Sterilization;Ethylene Oxide


[10813465011132]

Moist Heat or Steam Sterilization;Radiation Sterilization;Ethylene Oxide


[10813465011132]

Moist Heat or Steam Sterilization;Radiation Sterilization;Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-18
Device Publish Date2020-05-08

Devices Manufactured by HURRICANE MEDICAL INC

10813465011132 - IOL Manipulator - Lester2020-05-18Positioning of intraocular lens. Angled 10 mm from tip. Tip diameter 0.25 mm.
10813465011132 - IOL Manipulator - Lester2020-05-18 Positioning of intraocular lens. Angled 10 mm from tip. Tip diameter 0.25 mm.
10813465011149 - IOL Manipulator - Sinskey2020-05-18 Positioning of intraocular lens. Angled 15 mm from tip. Tip dimensions: diameter 0.20 mm, length 0.50 mm.
10813465011163 - IOL Manipulator - Sinskey2020-05-18 Positioning of intraocular lens. Straight. Tip dimensions: diameter 0.20 mm, length 0.50 mm.
10813465011170 - Nucleus Chopper - P. Koch2020-05-18 Used to break-up nucleus within capsular bag during phacoemulsification. Angled 6 mm from tip. Tip dimensions: diameter 0.30 mm,
10813465011187 - Nucleus Chopper - Beckingsale2020-05-18 Used to break-up nucleus within capsular bag during phacoemulsification. Angled 11 mm from tip. Tip dimensions: diameter 0.30 mm
10813465011194 - Silicone Tubing2020-05-15 Tubing is used for making products similar to 6023, 6025, and 6027.
10813465011316 - Marker Pad - Gentian Violet2020-05-15 Used to coat corneal markers to imprint pattern on cornea.
10813465011323 - Marker Pad - Methylene Blue2020-05-15 Used to coat corneal markers to imprint pattern on cornea.

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