SPHERZ: ILUMARK SNAP EASYFIT 2010-05

GUDID 00815212021428

Izi Medical Products, LLC

Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual
Primary Device ID00815212021428
NIH Device Record Keya8a30ba7-2a84-4255-9899-49b36ab66181
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPHERZ: ILUMARK SNAP EASYFIT 2010-05
Version Model Number2010-05
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
GS100815212021428 [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 Date2021-10-25
Device Publish Date2021-10-15

Devices Manufactured by Izi Medical Products, LLC

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00815212026812 - ONPOINT NAVIGATION KIT2024-03-06
00815212026829 - ONPOINT NAVIGATION TRAY2024-03-06
00815212026836 - ONPOINT SNAP SPHERZ 25PK2024-03-06
00815212026843 - ONPOINT SPHERZ PASSIVE MARKER-12 PACK2024-03-06
00815212026850 - ONPOINT PEDICLE ACCESS NEEDLE2024-03-06
10815212026819 - ONPOINT NAVIGATION 10 BOX2024-03-06
20815212026816 - ONPOINT NAVIGATION 25 BOXES2024-03-06

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