GemcisionTM Paracentesis, Super Sharp, Sharp Sides, Straight Blade Housing, 1.2m

GUDID 00840096215175

GemcisionTM Paracentesis, Super Sharp, Sharp Sides, Straight Blade Housing, 1.2mm Width

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
Primary Device ID00840096215175
NIH Device Record Key2fbbe0dd-37d2-4679-b8de-949f487d5280
Commercial Distribution StatusIn Commercial Distribution
Brand NameGemcisionTM Paracentesis, Super Sharp, Sharp Sides, Straight Blade Housing, 1.2m
Version Model Number7924-P12-60
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
GS100840096215175 [Primary]

FDA Product Code

HNNKnife, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840096215175]

Moist Heat or Steam Sterilization


[00840096215175]

Moist Heat or Steam Sterilization


[00840096215175]

Moist Heat or Steam Sterilization


[00840096215175]

Moist Heat or Steam Sterilization


[00840096215175]

Moist Heat or Steam Sterilization


[00840096215175]

Moist Heat or Steam Sterilization


[00840096215175]

Moist Heat or Steam Sterilization


[00840096215175]

Moist Heat or Steam Sterilization


[00840096215175]

Moist Heat or Steam Sterilization


[00840096215175]

Moist Heat or Steam Sterilization


[00840096215175]

Moist Heat or Steam Sterilization


[00840096215175]

Moist Heat or Steam Sterilization


[00840096215175]

Moist Heat or Steam Sterilization


[00840096215175]

Moist Heat or Steam Sterilization


[00840096215175]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-20
Device Publish Date2024-02-12

On-Brand Devices [GemcisionTM Paracentesis, Super Sharp, Sharp Sides, Straight Blade Housing, 1.2m]

10840096215172GemcisionTM Paracentesis, Super Sharp, Sharp Sides, Straight Blade Housing, 1.2mm Width/Box of 5
00840096215175GemcisionTM Paracentesis, Super Sharp, Sharp Sides, Straight Blade Housing, 1.2mm Width

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