ORTHO-KEY 2010-05-ORTHO

GUDID 00815212026720

Navigation Markers - Snap, Manufactured for ORTHO-KEY

Izi Medical Products, LLC

Radiographic image marker, manual
Primary Device ID00815212026720
NIH Device Record Key1f056467-8569-442f-95b2-6677e5126717
Commercial Distribution StatusIn Commercial Distribution
Brand NameORTHO-KEY
Version Model Number2010-05-ORTHO
Catalog Number2010-05-ORTHO
Company DUNS933506164
Company NameIzi Medical Products, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815212026720 [Package]
Contains: 00815212026737
Package: Box [40 Units]
In Commercial Distribution
GS100815212026737 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-14
Device Publish Date2023-06-06

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