Titanium Kuglen Iris Hook and Lens Manipulator, Angled

GUDID 00840096207910

KATALYST SURGICAL LLC

Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable
Primary Device ID00840096207910
NIH Device Record Key8f61cae8-329f-48dc-8aea-65de512952de
Commercial Distribution StatusIn Commercial Distribution
Brand NameTitanium Kuglen Iris Hook and Lens Manipulator, Angled
Version Model Number2000A
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
GS100840096207910 [Primary]

FDA Product Code

HNQHook, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840096207910]

Moist Heat or Steam Sterilization


[00840096207910]

Moist Heat or Steam Sterilization


[00840096207910]

Moist Heat or Steam Sterilization


[00840096207910]

Moist Heat or Steam Sterilization


[00840096207910]

Moist Heat or Steam Sterilization


[00840096207910]

Moist Heat or Steam Sterilization


[00840096207910]

Moist Heat or Steam Sterilization


[00840096207910]

Moist Heat or Steam Sterilization


[00840096207910]

Moist Heat or Steam Sterilization


[00840096207910]

Moist Heat or Steam Sterilization


[00840096207910]

Moist Heat or Steam Sterilization


[00840096207910]

Moist Heat or Steam Sterilization


[00840096207910]

Moist Heat or Steam Sterilization


[00840096207910]

Moist Heat or Steam Sterilization


[00840096207910]

Moist Heat or Steam Sterilization


[00840096207910]

Moist Heat or Steam Sterilization


[00840096207910]

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 Kuglen Iris Hook and Lens Manipulator, Angled]

008174890291762000A
008400962079102000A

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.