Prometheus Ankle System Bone Plate

GUDID 08806390896481

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 08806390896481
• NIH Device Record Key: a922a02c-973c-4ee3-8ffc-314cf015aae1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prometheus Ankle System Bone Plate
• Version Model Number: PRO-10354
• 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	08806390896481 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152158

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08806390896481]

Moist Heat or Steam Sterilization

[08806390896481]

Moist Heat or Steam Sterilization

[08806390896481]

Moist Heat or Steam Sterilization

[08806390896481]

Moist Heat or Steam Sterilization

[08806390896481]

Moist Heat or Steam Sterilization

[08806390896481]

Moist Heat or Steam Sterilization

[08806390896481]

Moist Heat or Steam Sterilization

[08806390896481]

Moist Heat or Steam Sterilization

[08806390896481]

Moist Heat or Steam Sterilization

[08806390896481]

Moist Heat or Steam Sterilization

[08806390896481]

Moist Heat or Steam Sterilization

[08806390896481]

Moist Heat or Steam Sterilization

[08806390896481]

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 Ankle System Bone Plate]

• 08806390896559: PRO-10366
• 08806390896542: PRO-10365
• 08806390896535: PRO-10364
• 08806390896528: PRO-10363
• 08806390896511: PRO-10362
• 08806390896504: PRO-10361
• 08806390896498: PRO-10360
• 08806390896481: PRO-10354
• 08806390896474: PRO-10359
• 08806390896467: PRO-10353
• 08806390896450: PRO-10358
• 08806390896443: PRO-10352
• 08806390896436: PRO-10357
• 08806390896429: PRO-10351
• 08806390896412: PRO-10356
• 08806390896405: PRO-10350
• 08806390896399: PRO-10355
• 08806390896382: PRO-10349