Prometheus Diaphysis System Bone Plate

GUDID 08806390896313

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 08806390896313
• NIH Device Record Key: 44e15868-eed8-4a5a-a6e9-c05ad3a74671
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prometheus Diaphysis System Bone Plate
• Version Model Number: PRO-10304
• 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	08806390896313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171285

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08806390896313]

Moist Heat or Steam Sterilization

[08806390896313]

Moist Heat or Steam Sterilization

[08806390896313]

Moist Heat or Steam Sterilization

[08806390896313]

Moist Heat or Steam Sterilization

[08806390896313]

Moist Heat or Steam Sterilization

[08806390896313]

Moist Heat or Steam Sterilization

[08806390896313]

Moist Heat or Steam Sterilization

[08806390896313]

Moist Heat or Steam Sterilization

[08806390896313]

Moist Heat or Steam Sterilization

[08806390896313]

Moist Heat or Steam Sterilization

[08806390896313]

Moist Heat or Steam Sterilization

[08806390896313]

Moist Heat or Steam Sterilization

[08806390896313]

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 Diaphysis System Bone Plate]

• 08806390897983: PRO-10303
• 08806390897976: PRO-10302
• 08806390897969: PRO-10301
• 08806390897952: PRO-10300
• 08806390897945: PRO-10299
• 08806390897938: PRO-10298
• 08806390897921: PRO-10297
• 08806390897914: PRO-10296
• 08806390897907: PRO-10295
• 08806390897891: PRO-10316
• 08806390897884: PRO-10315
• 08806390897877: PRO-10314
• 08806390897860: PRO-10313
• 08806390897853: PRO-10312
• 08806390897846: PRO-10311
• 08806390896375: PRO-10310
• 08806390896368: PRO-10309
• 08806390896351: PRO-10308
• 08806390896344: PRO-10307
• 08806390896337: PRO-10306
• 08806390896320: PRO-10305
• 08806390896313: PRO-10304