ARIX Sternal System Bone Screw

GUDID 08806390886369

Jeil Medical Corporation

Sternal fixation device Sternal fixation device Sternal fixation device
Primary Device ID08806390886369
NIH Device Record Key3fef31a0-2195-4276-8c6b-ddf3f7ff09a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameARIX Sternal System Bone Screw
Version Model NumberS27L-SA-010-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
GS108806390886369 [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 Date2020-05-18
Device Publish Date2020-05-08

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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