Surgical Glide 9201

GUDID 10813465012078

Placement of intraocular lens into the posterior chamber. Also protects iris from prolapse or trauma during surgical procedures. Thickness 6 mil. End radius 1.5 mm.

HURRICANE MEDICAL INC

Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use
Primary Device ID10813465012078
NIH Device Record Key55930315-05ca-4810-bb8a-1f3744936012
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurgical Glide
Version Model Number9201
Catalog Number9201
Company DUNS093377724
Company NameHURRICANE MEDICAL INC
Device Count50
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Width3 Millimeter
Length25 Millimeter
Width3 Millimeter
Length25 Millimeter
Width3 Millimeter
Length25 Millimeter
Width3 Millimeter
Length25 Millimeter
Width3 Millimeter
Length25 Millimeter
Width3 Millimeter
Length25 Millimeter
Width3 Millimeter
Length25 Millimeter
Width3 Millimeter
Length25 Millimeter
Width3 Millimeter
Length25 Millimeter
Width3 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100813465012071 [Primary]
GS110813465012078 [Unit of Use]

FDA Product Code

KYBLens, Guide, Intraocular

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10813465012078]

Radiation Sterilization;Ethylene Oxide


[10813465012078]

Radiation Sterilization;Ethylene Oxide


[10813465012078]

Radiation Sterilization;Ethylene Oxide


[10813465012078]

Radiation Sterilization;Ethylene Oxide


[10813465012078]

Radiation Sterilization;Ethylene Oxide


[10813465012078]

Radiation Sterilization;Ethylene Oxide


[10813465012078]

Radiation Sterilization;Ethylene Oxide


[10813465012078]

Radiation Sterilization;Ethylene Oxide


[10813465012078]

Radiation Sterilization;Ethylene Oxide


[10813465012078]

Radiation Sterilization;Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-13
Device Publish Date2020-05-05

Devices Manufactured by HURRICANE MEDICAL INC

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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