Bores Optic Zone Marker, 9.0mm

GUDID 00840096203493

KATALYST SURGICAL LLC

Corneal marker, reusable
Primary Device ID00840096203493
NIH Device Record Keycb109828-0b25-476a-a5e5-919c1a9a77f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameBores Optic Zone Marker, 9.0mm
Version Model Number8511-9
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
GS100840096203493 [Primary]

FDA Product Code

HMRMarker, Ocular

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840096203493]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-03
Device Publish Date2019-06-25

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