ARIX Sternal System Bone Screw

GUDID 08800089434022

Jeil Medical Corporation

Sternal fixation device

• Primary Device ID: 08800089434022
• NIH Device Record Key: 9339d8fd-55ac-409c-a655-735caebafd3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARIX Sternal System Bone Screw
• Version Model Number: 24L-SA-S13-TA
• 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: false
• 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	08800089434022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181806

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[08800089434022]

Moist Heat or Steam Sterilization

[08800089434022]

Moist Heat or Steam Sterilization

[08800089434022]

Moist Heat or Steam Sterilization

[08800089434022]

Moist Heat or Steam Sterilization

[08800089434022]

Moist Heat or Steam Sterilization

[08800089434022]

Moist Heat or Steam Sterilization

[08800089434022]

Moist Heat or Steam Sterilization

[08800089434022]

Moist Heat or Steam Sterilization

[08800089434022]

Moist Heat or Steam Sterilization

[08800089434022]

Moist Heat or Steam Sterilization

[08800089434022]

Moist Heat or Steam Sterilization

[08800089434022]

Moist Heat or Steam Sterilization

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