Titanium Double-Ended Capsule Polisher

GUDID 00840096205855

KATALYST SURGICAL LLC

Ophthalmic curette, reusable Ophthalmic curette, reusable Ophthalmic curette, reusable Ophthalmic curette, reusable Ophthalmic curette, reusable Ophthalmic curette, reusable Ophthalmic curette, reusable Ophthalmic curette, reusable Ophthalmic curette, reusable Ophthalmic curette, reusable Ophthalmic curette, reusable Ophthalmic curette, reusable Ophthalmic curette, reusable Ophthalmic curette, reusable Ophthalmic curette, reusable Ophthalmic curette, reusable Ophthalmic curette, reusable
Primary Device ID00840096205855
NIH Device Record Key466b2e03-a699-4c42-96af-3cd56123f2e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameTitanium Double-Ended Capsule Polisher
Version Model Number1602D
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
GS100840096205855 [Primary]

FDA Product Code

FZSCurette, Surgical, General Use

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840096205855]

Moist Heat or Steam Sterilization


[00840096205855]

Moist Heat or Steam Sterilization


[00840096205855]

Moist Heat or Steam Sterilization


[00840096205855]

Moist Heat or Steam Sterilization


[00840096205855]

Moist Heat or Steam Sterilization


[00840096205855]

Moist Heat or Steam Sterilization


[00840096205855]

Moist Heat or Steam Sterilization


[00840096205855]

Moist Heat or Steam Sterilization


[00840096205855]

Moist Heat or Steam Sterilization


[00840096205855]

Moist Heat or Steam Sterilization


[00840096205855]

Moist Heat or Steam Sterilization


[00840096205855]

Moist Heat or Steam Sterilization


[00840096205855]

Moist Heat or Steam Sterilization


[00840096205855]

Moist Heat or Steam Sterilization


[00840096205855]

Moist Heat or Steam Sterilization


[00840096205855]

Moist Heat or Steam Sterilization


[00840096205855]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-29
Device Publish Date2023-03-21

On-Brand Devices [Titanium Double-Ended Capsule Polisher]

008400962001571602D
008400962058551602D

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