LASIK Incise Film 7309

GUDID 10813465011354

Cover lashes, lids, and brows for LASIK, other refractive, or office procedures. Adhesive area 10 x 8.75 cm.

HURRICANE MEDICAL INC

Hypoallergenic skin adhesive tape
Primary Device ID10813465011354
NIH Device Record Key14b59a37-5097-44d0-824f-cfb6e5a58510
Commercial Distribution StatusIn Commercial Distribution
Brand NameLASIK Incise Film
Version Model Number7309
Catalog Number7309
Company DUNS093377724
Company NameHURRICANE MEDICAL INC
Device Count20
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

Width10 Centimeter
Length12.5 Centimeter
Width10 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100813465011357 [Primary]
GS110813465011354 [Unit of Use]

FDA Product Code

KGXTape And Bandage, Adhesive

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10813465011354]

Radiation Sterilization;Ethylene Oxide


[10813465011354]

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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