Prometheus Wrist System Bone Plate

GUDID 08806390894838

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 08806390894838
• NIH Device Record Key: 3a3ff0b6-2038-4b9f-83dd-0117d847a47b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prometheus Wrist System Bone Plate
• Version Model Number: PRO-10409
• 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	08806390894838 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191972

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08806390894838]

Moist Heat or Steam Sterilization

[08806390894838]

Moist Heat or Steam Sterilization

[08806390894838]

Moist Heat or Steam Sterilization

[08806390894838]

Moist Heat or Steam Sterilization

[08806390894838]

Moist Heat or Steam Sterilization

[08806390894838]

Moist Heat or Steam Sterilization

[08806390894838]

Moist Heat or Steam Sterilization

[08806390894838]

Moist Heat or Steam Sterilization

[08806390894838]

Moist Heat or Steam Sterilization

[08806390894838]

Moist Heat or Steam Sterilization

[08806390894838]

Moist Heat or Steam Sterilization

[08806390894838]

Moist Heat or Steam Sterilization

[08806390894838]

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 Wrist System Bone Plate]

• 08806390894890: PRO-10419
• 08806390894883: PRO-10420
• 08806390894876: PRO-10411
• 08806390894869: PRO-10412
• 08806390894852: PRO-10417
• 08806390894845: PRO-10418
• 08806390894838: PRO-10409
• 08806390894821: PRO-10410
• 08806390894609: PRO-10423
• 08806390894593: PRO-10424
• 08806390894586: PRO-10415
• 08806390894579: PRO-10416
• 08806390894562: PRO-10421
• 08806390894555: PRO-10422
• 08806390894548: PRO-10413
• 08806390894531: PRO-10414
• 08806390894524: PRO-10393
• 08806390894517: PRO-10394
• 08806390894500: PRO-10391
• 08806390894494: PRO-10392
• 08806390894487: PRO-10389
• 08806390894470: PRO-10390
• 08806390894463: PRO-10387
• 08806390894456: PRO-10388
• 08806390894449: PRO-10385
• 08806390894432: PRO-10386
• 08806390894425: PRO-10383
• 08806390894418: PRO-10384
• 08806390894401: PRO-10381
• 08806390894395: PRO-10382
• 08806390894388: PRO-10379
• 08806390894371: PRO-10380
• 08806390894364: PRO-10377
• 08806390894357: PRO-10378