ARIX Sternal System Bone Screw

GUDID 08800089433629

Jeil Medical Corporation

Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device

• Primary Device ID: 08800089433629
• NIH Device Record Key: 931c8faf-8902-4797-a026-7397e16d2270
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARIX Sternal System Bone Screw
• Version Model Number: S24L-SA-S09-TA-4
• Company DUNS: 688811603
• Company Name: Jeil Medical Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800089433629 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181806

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-14
• Device Publish Date: 2022-12-06

On-Brand Devices [ARIX Sternal System Bone Screw]

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