Prometheus Hand System Bone Plate

GUDID 08806390899536

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 08806390899536
• NIH Device Record Key: 51decf50-e811-4740-a4b6-9530decb56db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prometheus Hand System Bone Plate
• Version Model Number: PRO-10612
• 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	08806390899536 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161746

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08806390899536]

Moist Heat or Steam Sterilization

[08806390899536]

Moist Heat or Steam Sterilization

[08806390899536]

Moist Heat or Steam Sterilization

[08806390899536]

Moist Heat or Steam Sterilization

[08806390899536]

Moist Heat or Steam Sterilization

[08806390899536]

Moist Heat or Steam Sterilization

[08806390899536]

Moist Heat or Steam Sterilization

[08806390899536]

Moist Heat or Steam Sterilization

[08806390899536]

Moist Heat or Steam Sterilization

[08806390899536]

Moist Heat or Steam Sterilization

[08806390899536]

Moist Heat or Steam Sterilization

[08806390899536]

Moist Heat or Steam Sterilization

[08806390899536]

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 Hand System Bone Plate]

• 08806390899789: PRO-10619
• 08806390899772: PRO-10618
• 08806390899765: PRO-10627
• 08806390899758: PRO-10617
• 08806390899741: PRO-10626
• 08806390899734: PRO-10625
• 08806390899727: PRO-10624
• 08806390899710: PRO-10623
• 08806390899703: PRO-10622
• 08806390899697: PRO-10615
• 08806390899680: PRO-10614
• 08806390899673: PRO-10613
• 08806390899666: PRO-10616
• 08806390899659: PRO-10631
• 08806390899642: PRO-10629
• 08806390899635: PRO-10621
• 08806390899628: PRO-10630
• 08806390899611: PRO-10628
• 08806390899604: PRO-10620
• 08806390899598: PRO-10610
• 08806390899581: PRO-10609
• 08806390899574: PRO-10607
• 08806390899567: PRO-10606
• 08806390899550: PRO-10605
• 08806390899543: PRO-10608
• 08806390899536: PRO-10612
• 08806390899529: PRO-10611