Prometheus Humerus System Bone Plate

GUDID 08806390897365

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 08806390897365
• NIH Device Record Key: 53c26581-1a72-48b5-9805-131e91cb9ab5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prometheus Humerus System Bone Plate
• Version Model Number: PRO-10665
• 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	08806390897365 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172008

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08806390897365]

Moist Heat or Steam Sterilization

[08806390897365]

Moist Heat or Steam Sterilization

[08806390897365]

Moist Heat or Steam Sterilization

[08806390897365]

Moist Heat or Steam Sterilization

[08806390897365]

Moist Heat or Steam Sterilization

[08806390897365]

Moist Heat or Steam Sterilization

[08806390897365]

Moist Heat or Steam Sterilization

[08806390897365]

Moist Heat or Steam Sterilization

[08806390897365]

Moist Heat or Steam Sterilization

[08806390897365]

Moist Heat or Steam Sterilization

[08806390897365]

Moist Heat or Steam Sterilization

[08806390897365]

Moist Heat or Steam Sterilization

[08806390897365]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-09
• Device Publish Date: 2020-09-01

On-Brand Devices [Prometheus Humerus System Bone Plate]

• 08806390897419: PRO-10670
• 08806390897402: PRO-10667
• 08806390897396: PRO-10669
• 08806390897389: PRO-10666
• 08806390897372: PRO-10668
• 08806390897365: PRO-10665