Snap On Spherz

GUDID 00815212020629

Izi Medical Products, LLC

Radiographic image marker, manual
Primary Device ID00815212020629
NIH Device Record Key188e99bf-7064-4a19-8cea-a03f985d45ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameSnap On Spherz
Version Model NumberPM8015
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
GS100815212020629 [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 Date2016-11-07

On-Brand Devices [Snap On Spherz]

00815212022999PM8012B
008152120229372010-40
008152120214732010-200
008152120214662010-160
008152120214592010-130
008152120214422010-120
008152120214352010-100
008152120214112010-04
008152120214048100-4004
008152120213988100-4003
008152120213810100704
008152120213740100703
008152120213672010-03
008152120213502010-02
008152120213432010-01
00815212020698PM8108
00815212020681PM8060
00815212020674PM8048
00815212020667PM8035
00815212020650PM8030
00815212020643PM8025
00815212020636PM8020
00815212020629PM8015
00815212020612PM8012
00815212020605PM8010
00815212020599PM8009
00815212020582PM8005
00815212020575PM8004
00815212020568PM8003
00815212020551PM8001
00815212020544PM1010-I
00815212020537PM1010
00815212023460PM8004-7D
00815212023453PM8001-7D
008152120244122010-03-ORTHO
008152120244052010-120-ORTHO

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