GemcisionTM Paracentesis, Super Sharp, .75mm Width, Angled/Box of 5

GUDID 00840096207095

GemcisionTM Paracentesis, Super Sharp, .75mm Width, Angled/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
Primary Device ID00840096207095
NIH Device Record Key1c406543-aac7-4e10-b1a3-5bfa9043a2f6
Commercial Distribution Discontinuation2022-12-08
Commercial Distribution StatusNot in Commercial Distribution
Brand NameGemcisionTM Paracentesis, Super Sharp, .75mm Width, Angled/Box of 5
Version Model Number7900-P75-60Ab
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
GS100840096207095 [Primary]

FDA Product Code

HNNKnife, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840096207095]

Moist Heat or Steam Sterilization


[00840096207095]

Moist Heat or Steam Sterilization


[00840096207095]

Moist Heat or Steam Sterilization


[00840096207095]

Moist Heat or Steam Sterilization


[00840096207095]

Moist Heat or Steam Sterilization


[00840096207095]

Moist Heat or Steam Sterilization


[00840096207095]

Moist Heat or Steam Sterilization


[00840096207095]

Moist Heat or Steam Sterilization


[00840096207095]

Moist Heat or Steam Sterilization


[00840096207095]

Moist Heat or Steam Sterilization


[00840096207095]

Moist Heat or Steam Sterilization


[00840096207095]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-12-09
Device Publish Date2020-06-05

On-Brand Devices [GemcisionTM Paracentesis, Super Sharp, .75mm Width, Angled/Box of 5]

108400962009947900-P75-60A
00840096207095GemcisionTM Paracentesis, Super Sharp, .75mm Width, Angled/Box of 5

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