SPHERZ: ILUMARK QUICK TWIST 2021-02

GUDID 00815212021589

Izi Medical Products, LLC

Radiographic image marker, manual
Primary Device ID00815212021589
NIH Device Record Key324cd4d4-b4d0-4666-a92c-e62ee25e59a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPHERZ: ILUMARK QUICK TWIST 2021-02
Version Model Number2021-02
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
GS100815212021589 [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

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00815212026904 - OsteoPearl Vertebral Balloon (15mm) & Inflation Device Kit, 10G2024-08-13
00815212024467 - STRYKER NAVIGATED BIOPSY NEEDLE2024-08-07
00815212026874 - BKP-10-12.0-15.0-A2024-07-08
00815212026881 - BKP-11-12.0-15.0-A2024-07-08

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