ARIX Hand System Bone Plate

GUDID 08809282811319

Jeil Medical Corporation

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: 08809282811319
• NIH Device Record Key: 43c9cd20-e483-4fc8-a338-574c449b9d93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARIX Hand System Bone Plate
• Version Model Number: H2-YP-007
• 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	08809282811319 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131566

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08809282811319]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-11
• Device Publish Date: 2015-09-24

On-Brand Devices [ARIX Hand System Bone Plate]

• 08809282815256: H1-YP-006A
• 08809282811326: H2-ZZ-016
• 08809282811319: H2-YP-007
• 08809282811302: H2-TP-012
• 08809282811296: H2-TP-011
• 08809282811289: H2-TP-010-CP
• 08809282811272: H2-TP-007
• 08809282811265: H2-TP-006-CP
• 08809282811258: H2-TP-006
• 08809282811241: H2-ST-216
• 08809282811227: H2-ST-106-CP
• 08809282811210: H2-ST-105-CP
• 08809282811203: H2-ST-104-CP
• 08809282811197: H2-ST-104
• 08809282811180: H2-ST-016
• 08809282811173: H2-ST-006
• 08809282811166: H2-SQ-304-R
• 08809282811159: H2-SQ-304-L
• 08809282811142: H2-SQ-204
• 08809282811135: H2-SQ-104
• 08809282811128: H2-QD-408-R
• 08809282811111: H2-QD-408-L
• 08809282811104: H2-QD-306-R
• 08809282811098: H2-QD-306-L
• 08809282811081: H2-QD-206-R
• 08809282811074: H2-QD-206-L
• 08809282811067: H2-QD-112
• 08809282811050: H2-QD-110
• 08809282811043: H2-QD-108
• 08809282811036: H2-QD-106
• 08809282811029: H2-QD-006
• 08809282811012: H2-PR-006
• 08809282811005: H2-PL-006
• 08809282810992: H2-LR-010-CP
• 08809282810985: H2-LR-006-CP
• 08809282810978: H2-LR-006
• 08809282810961: H2-LL-010-CP
• 08809282810954: H2-LL-006-CP
• 08809282810947: H2-LL-006
• 08809282810824: H1-ZZ-016
• 08809282810817: H1-YP-006
• 08809282810800: H1-TP-012
• 08809282810794: H1-TP-011
• 08809282810787: H1-TP-010
• 08809282810770: H1-TP-008
• 08809282810763: H1-TP-007
• 08809282810756: H1-ST-216
• 08809282810749: H1-ST-104
• 08809282810732: H1-ST-016
• 08809282810725: H1-ST-006