Threaded Spherz

GUDID 00815212021541

Izi Medical Products, LLC

Radiographic image marker, manual
Primary Device ID00815212021541
NIH Device Record Keycc849b93-4221-400a-b605-f543622c5d5a
Commercial Distribution StatusIn Commercial Distribution
Brand NameThreaded Spherz
Version Model Number2020-130
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
GS100815212021541 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-29

On-Brand Devices [Threaded Spherz]

008152120215652020-40
008152120215582020-160
008152120215412020-130
008152120215342020-120
008152120215272020-100
008152120215102020-04
008152120215032020-03
008152120214972020-02
008152120214802020-01
00815212020469TS2090
00815212020452TS2005
00815212020445TS2004
00815212020438TS2003
00815212020421TS2002
00815212020414TS2001
00815212020407TS1010
008152120244362020-120-CAS

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