Titanium Henderson Degree Gauge

GUDID 00840096200638

KATALYST SURGICAL LLC

Ophthalmic angular gauge, reusable
Primary Device ID00840096200638
NIH Device Record Key2784b265-09e7-40a1-a3ad-cfd0b393fdcb
Commercial Distribution StatusIn Commercial Distribution
Brand NameTitanium Henderson Degree Gauge
Version Model Number8505
Company DUNS007883297
Company NameKATALYST SURGICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Conditional
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
GS100840096200638 [Primary]

FDA Product Code

HMRMarker, Ocular

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840096200638]

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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