Titanium Mendez Degree Gauge

GUDID 00840096200621

KATALYST SURGICAL LLC

Ophthalmic angular gauge, reusable
Primary Device ID00840096200621
NIH Device Record Key61c537ad-facd-4c69-b8bf-687875e53dca
Commercial Distribution StatusIn Commercial Distribution
Brand NameTitanium Mendez Degree Gauge
Version Model Number8500
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
GS100840096200621 [Primary]

FDA Product Code

HMRMarker, Ocular

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840096200621]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-10-07
Device Publish Date2019-06-24

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