GemcisionTM Paracentesis, Super Sharp, 1mm Width, 30°/Box of 5

GUDID 00840096215083

GemcisionTM Paracentesis, Super Sharp, 1mm Width, 30°/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 Ophthalmic knife, reusable Ophthalmic knife, reusable
Primary Device ID00840096215083
NIH Device Record Keyf0fc5385-af40-4bfa-8e39-ff09430f8502
Commercial Distribution StatusIn Commercial Distribution
Brand NameGemcisionTM Paracentesis, Super Sharp, 1mm Width, 30°/Box of 5
Version Model Number7990-P1b
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
GS100840096215083 [Primary]

FDA Product Code

HNNKnife, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840096215083]

Moist Heat or Steam Sterilization


[00840096215083]

Moist Heat or Steam Sterilization


[00840096215083]

Moist Heat or Steam Sterilization


[00840096215083]

Moist Heat or Steam Sterilization


[00840096215083]

Moist Heat or Steam Sterilization


[00840096215083]

Moist Heat or Steam Sterilization


[00840096215083]

Moist Heat or Steam Sterilization


[00840096215083]

Moist Heat or Steam Sterilization


[00840096215083]

Moist Heat or Steam Sterilization


[00840096215083]

Moist Heat or Steam Sterilization


[00840096215083]

Moist Heat or Steam Sterilization


[00840096215083]

Moist Heat or Steam Sterilization


[00840096215083]

Moist Heat or Steam Sterilization


[00840096215083]

Moist Heat or Steam Sterilization


[00840096215083]

Moist Heat or Steam Sterilization


[00840096215083]

Moist Heat or Steam Sterilization


[00840096215083]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-10
Device Publish Date2023-03-31

On-Brand Devices [GemcisionTM Paracentesis, Super Sharp, 1mm Width, 30°/Box of 5]

008400962013837990-P1
00840096215083GemcisionTM Paracentesis, Super Sharp, 1mm Width, 30°/Box of 5

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