ARIX System Bone Screw

GUDID 08806390884884

Jeil Medical Corporation

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 08806390884884
• NIH Device Record Key: 63b34f60-3661-4a71-be96-f93c5a4fdf84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARIX System Bone Screw
• Version Model Number: 25P-SO-026-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	08806390884884 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191972

FDA Product Code

• LXT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Sterilization

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

[08806390884884]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-28
• Device Publish Date: 2020-04-20

On-Brand Devices [ARIX System Bone Screw]

• 08809282819797: 25-HF-030
• 08809282819780: 25L-HF-030
• 08809282819773: 25L-HF-028
• 08809282819766: 25L-HF-026
• 08809282819759: 25-HF-028
• 08809282819742: 25-HF-026
• 08809282819681: 25L-HF-008
• 08809282819674: 25-HF-008
• 08809282819582: 25-HF-010
• 08809282819575: 25L-HF-010
• 08809282819032: 25-HF-024
• 08809282819025: 25-HF-022
• 08809282819018: 25-HF-020
• 08809282819001: 25-HF-018
• 08809282818998: 25-HF-016
• 08809282818981: 25-HF-014
• 08809282818974: 25-HF-012
• 08809282818967: 25L-HF-024
• 08809282818950: 25L-HF-022
• 08809282818943: 25L-HF-020
• 08809282818936: 25L-HF-018
• 08809282818929: 25L-HF-016
• 08809282818912: 25L-HF-014
• 08809282818905: 25L-HF-012
• 08809282813801: 30-CH-030L
• 08809282813795: 30-CH-030
• 08809282813665: 30-CH-023L
• 08809282813009: 28L-HF-045
• 08809282812996: 28L-HF-040
• 08809282812989: 28L-HF-038
• 08809282812972: 28L-HF-036
• 08809282812965: 28L-HF-034
• 08809282812958: 28L-HF-032
• 08809282812941: 28L-HF-030
• 08809282812934: 28L-HF-028
• 08809282812927: 28L-HF-026
• 08809282812910: 28L-HF-024
• 08809282812903: 28L-HF-022
• 08809282812897: 28L-HF-020
• 08809282812880: 28L-HF-018
• 08809282812873: 28L-HF-016
• 08809282812866: 28L-HF-014
• 08809282812859: 28L-HF-012
• 08809282812842: 28L-HF-010
• 08809282812835: 28L-HF-008
• 08809282810190: 12-HC-012
• 08809282810183: 12-HC-011
• 08809282810077: 12-HC-010
• 08809282810060: 12-HC-009
• 08809282810053: 12-HC-008