Prometheus Foot System Bone Plate

GUDID 08806390898782

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 08806390898782
• NIH Device Record Key: ae4061fe-8165-437a-a05a-b73b49c72541
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prometheus Foot System Bone Plate
• Version Model Number: PRO-10489
• 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	08806390898782 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170780

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08806390898782]

Moist Heat or Steam Sterilization

[08806390898782]

Moist Heat or Steam Sterilization

[08806390898782]

Moist Heat or Steam Sterilization

[08806390898782]

Moist Heat or Steam Sterilization

[08806390898782]

Moist Heat or Steam Sterilization

[08806390898782]

Moist Heat or Steam Sterilization

[08806390898782]

Moist Heat or Steam Sterilization

[08806390898782]

Moist Heat or Steam Sterilization

[08806390898782]

Moist Heat or Steam Sterilization

[08806390898782]

Moist Heat or Steam Sterilization

[08806390898782]

Moist Heat or Steam Sterilization

[08806390898782]

Moist Heat or Steam Sterilization

[08806390898782]

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 Foot System Bone Plate]

• 08806390899512: PRO-10544
• 08806390899505: PRO-10543
• 08806390899499: PRO-10542
• 08806390899482: PRO-10541
• 08806390899475: PRO-10540
• 08806390899468: PRO-10539
• 08806390899451: PRO-10552
• 08806390899444: PRO-10551
• 08806390899437: PRO-10550
• 08806390899420: PRO-10549
• 08806390899413: PRO-10486
• 08806390899406: PRO-10485
• 08806390899390: PRO-10484
• 08806390899383: PRO-10483
• 08806390899376: PRO-10482
• 08806390899369: PRO-10500
• 08806390899352: PRO-10499
• 08806390899345: PRO-10498
• 08806390899338: PRO-10497
• 08806390899321: PRO-10532
• 08806390899314: PRO-10531
• 08806390899307: PRO-10530
• 08806390899291: PRO-10529
• 08806390899284: PRO-10528
• 08806390899277: PRO-10527
• 08806390899260: PRO-10526
• 08806390899253: PRO-10525
• 08806390899246: PRO-10524
• 08806390899239: PRO-10523
• 08806390899222: PRO-10522
• 08806390899215: PRO-10521
• 08806390899208: PRO-10520
• 08806390899192: PRO-10519
• 08806390899185: PRO-10518
• 08806390899178: PRO-10517
• 08806390899161: PRO-10492
• 08806390899154: PRO-10491
• 08806390899147: PRO-10490
• 08806390899130: PRO-10538
• 08806390899123: PRO-10537
• 08806390899116: PRO-10536
• 08806390899109: PRO-10535
• 08806390899093: PRO-10534
• 08806390899086: PRO-10533
• 08806390899079: PRO-10548
• 08806390899062: PRO-10547
• 08806390899055: PRO-10546
• 08806390899048: PRO-10545
• 08806390899031: PRO-10481
• 08806390899024: PRO-10480