Milder Phaco Chopper, Double Ended

GUDID 00840096206708

Milder Phaco Chopper, Double Ended

KATALYST SURGICAL LLC

Ocular hook/spatula/manipulator, reusable Ocular hook/spatula/manipulator, reusable Ocular hook/spatula/manipulator, reusable Ocular hook/spatula/manipulator, reusable Ocular hook/spatula/manipulator, reusable Ocular hook/spatula/manipulator, reusable Ocular hook/spatula/manipulator, reusable Ocular hook/spatula/manipulator, reusable Ocular hook/spatula/manipulator, reusable Ocular hook/spatula/manipulator, reusable Ocular hook/spatula/manipulator, reusable
Primary Device ID00840096206708
NIH Device Record Key2d727906-e35c-408d-923f-f1996edf8791
Commercial Distribution StatusIn Commercial Distribution
Brand NameMilder Phaco Chopper, Double Ended
Version Model Number5514
Company DUNS007883297
Company NameKATALYST SURGICAL LLC
Device Count1
DM Exemptfalse
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840096206708 [Primary]
GS100840096206708 [Primary]
GS100840096206708 [Primary]
GS100840096206708 [Primary]
GS100840096206708 [Primary]
GS100840096206708 [Primary]
GS100840096206708 [Primary]
GS100840096206708 [Primary]
GS100840096206708 [Primary]
GS100840096206708 [Primary]
GS100840096206708 [Primary]

FDA Product Code

HNQHook, Ophthalmic
HNQHook, Ophthalmic
HNQHook, Ophthalmic
HNQHook, Ophthalmic
HNQHook, Ophthalmic
HNQHook, Ophthalmic
HNQHook, Ophthalmic
HNQHook, Ophthalmic
HNQHook, Ophthalmic
HNQHook, Ophthalmic
HNQHook, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840096206708]

Moist Heat or Steam Sterilization


[00840096206708]

Moist Heat or Steam Sterilization


[00840096206708]

Moist Heat or Steam Sterilization


[00840096206708]

Moist Heat or Steam Sterilization


[00840096206708]

Moist Heat or Steam Sterilization


[00840096206708]

Moist Heat or Steam Sterilization


[00840096206708]

Moist Heat or Steam Sterilization


[00840096206708]

Moist Heat or Steam Sterilization


[00840096206708]

Moist Heat or Steam Sterilization


[00840096206708]

Moist Heat or Steam Sterilization


[00840096206708]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-26
Device Publish Date2020-05-18

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