GemcisionTM 250 Micron Blade, LRI

GUDID 20840096207341

GemcisionTM 250 Micron Blade, LRI

KATALYST SURGICAL LLC

Ophthalmic knife, reusable Ophthalmic knife, reusable Ophthalmic knife, reusable Ophthalmic knife, reusable Ophthalmic knife, reusable Ophthalmic knife, reusable Ophthalmic knife, reusable Ophthalmic knife, reusable Ophthalmic knife, reusable Ophthalmic knife, reusable Ophthalmic knife, reusable Ophthalmic knife, reusable Ophthalmic knife, reusable Ophthalmic knife, reusable Ophthalmic knife, reusable Ophthalmic knife, reusable Ophthalmic knife, reusable
Primary Device ID20840096207341
NIH Device Record Keyc998acd5-0f6c-4486-829c-34f66c3ba63d
Commercial Distribution StatusIn Commercial Distribution
Brand NameGemcisionTM 250 Micron Blade, LRI
Version Model Number7950-L250b
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
GS120840096207341 [Primary]

FDA Product Code

HNNKnife, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[20840096207341]

Moist Heat or Steam Sterilization


[20840096207341]

Moist Heat or Steam Sterilization


[20840096207341]

Moist Heat or Steam Sterilization


[20840096207341]

Moist Heat or Steam Sterilization


[20840096207341]

Moist Heat or Steam Sterilization


[20840096207341]

Moist Heat or Steam Sterilization


[20840096207341]

Moist Heat or Steam Sterilization


[20840096207341]

Moist Heat or Steam Sterilization


[20840096207341]

Moist Heat or Steam Sterilization


[20840096207341]

Moist Heat or Steam Sterilization


[20840096207341]

Moist Heat or Steam Sterilization


[20840096207341]

Moist Heat or Steam Sterilization


[20840096207341]

Moist Heat or Steam Sterilization


[20840096207341]

Moist Heat or Steam Sterilization


[20840096207341]

Moist Heat or Steam Sterilization


[20840096207341]

Moist Heat or Steam Sterilization


[20840096207341]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-16
Device Publish Date2023-06-08

On-Brand Devices [GemcisionTM 250 Micron Blade, LRI]

00840096207347GemcisionTM 250 Micron Blade, LRI
20840096207341GemcisionTM 250 Micron Blade, LRI

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