GemcisionTM Paracentesis, Super Sharp, Sharp Sides, Straight Blade Housing, Trun

GUDID 10840096215165

GemcisionTM Paracentesis, Super Sharp, Sharp Sides, Straight Blade Housing, Truncated, 1.0mm Width/Box of 5

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 ID10840096215165
NIH Device Record Key312d8e01-9263-4428-a1bc-d6ab29ed0e41
Commercial Distribution StatusIn Commercial Distribution
Brand NameGemcisionTM Paracentesis, Super Sharp, Sharp Sides, Straight Blade Housing, Trun
Version Model Number7924-P1-60Tb
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
GS110840096215165 [Primary]

FDA Product Code

HNNKnife, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10840096215165]

Moist Heat or Steam Sterilization


[10840096215165]

Moist Heat or Steam Sterilization


[10840096215165]

Moist Heat or Steam Sterilization


[10840096215165]

Moist Heat or Steam Sterilization


[10840096215165]

Moist Heat or Steam Sterilization


[10840096215165]

Moist Heat or Steam Sterilization


[10840096215165]

Moist Heat or Steam Sterilization


[10840096215165]

Moist Heat or Steam Sterilization


[10840096215165]

Moist Heat or Steam Sterilization


[10840096215165]

Moist Heat or Steam Sterilization


[10840096215165]

Moist Heat or Steam Sterilization


[10840096215165]

Moist Heat or Steam Sterilization


[10840096215165]

Moist Heat or Steam Sterilization


[10840096215165]

Moist Heat or Steam Sterilization


[10840096215165]

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, Trun]

10840096215165GemcisionTM Paracentesis, Super Sharp, Sharp Sides, Straight Blade Housing, Truncated, 1.0mm Wid
00840096215168GemcisionTM Paracentesis, Super Sharp, Sharp Sides, Straight Blade Housing, Truncated, 1.0mm Wid

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