ARIX Sternal System Bone Screw

GUDID 08806390881654

Jeil Medical Corporation

Sternal fixation device
Primary Device ID08806390881654
NIH Device Record Key6d6dd560-0e09-4ac7-83c0-ed5ac62384d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameARIX Sternal System Bone Screw
Version Model NumberS24L-SA-S12-TA-2
Company DUNS688811603
Company NameJeil Medical Corporation
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806390881654 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-08
Device Publish Date2020-06-30

On-Brand Devices [ARIX Sternal System Bone Screw]

08806390886451S27L-SA-018-TA-4
08806390886444S27L-SA-018-TA-2
08806390886437S27L-SA-016-TA-4
08806390886420S27L-SA-016-TA-2
08806390886413S27L-SA-014-TA-4
08806390886406S27L-SA-014-TA-2
08806390886390S27L-SA-012-TA-4
08806390886383S27L-SA-012-TA-2
08806390886376S27L-SA-010-TA-4
08806390886369S27L-SA-010-TA-2
08806390886352S27L-SA-008-TA-4
08806390886345S27L-SA-008-TA-2
08806390886338S24L-SA-018-TA-4
08806390886321S24L-SA-018-TA-2
08806390886314S24L-SA-016-TA-4
08806390886307S24L-SA-016-TA-2
08806390886291S24L-SA-014-TA-4
08806390886284S24L-SA-014-TA-2
08806390886277S24L-SA-012-TA-4
08806390886260S24L-SA-012-TA-2
08806390886253S24L-SA-010-TA-4
08806390886246S24L-SA-010-TA-2
08806390886239S24L-SA-008-TA-4
08806390886222S24L-SA-008-TA-2
08806390881968S27L-SA-S18-TA-4
08806390881951S27L-SA-S18-TA-2
08806390881944S27L-SA-S18-TA
08806390881937S27L-SA-S16-TA-4
08806390881920S27L-SA-S16-TA-2
08806390881913S27L-SA-S16-TA
08806390881906S27L-SA-S14-TA-4
08806390881890S27L-SA-S14-TA-2
08806390881883S27L-SA-S14-TA
08806390881876S27L-SA-S12-TA-4
08806390881869S27L-SA-S12-TA-2
08806390881852S27L-SA-S12-TA
08806390881845S27L-SA-S10-TA-4
08806390881838S27L-SA-S10-TA-2
08806390881821S27L-SA-S10-TA
08806390881814S27L-SA-S08-TA-4
08806390881807S27L-SA-S08-TA-2
08806390881791S27L-SA-S08-TA
08806390881753S24L-SA-S18-TA-4
08806390881746S24L-SA-S18-TA-2
08806390881739S24L-SA-S18-TA
08806390881722S24L-SA-S16-TA-4
08806390881715S24L-SA-S16-TA-2
08806390881708S24L-SA-S16-TA
08806390881692S24L-SA-S14-TA-4
08806390881685S24L-SA-S14-TA-2
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