VERUM Ankle System Bone Plate

GUDID 08806390859943

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 08806390859943
• NIH Device Record Key: 5904c1e9-5e66-4490-a529-bdd93beccfb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERUM Ankle System Bone Plate
• Version Model Number: PA1100
• 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	08806390859943 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152158

FDA Product Code

• KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

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

[08806390859943]

Moist Heat or Steam Sterilization

[08806390859943]

Moist Heat or Steam Sterilization

[08806390859943]

Moist Heat or Steam Sterilization

[08806390859943]

Moist Heat or Steam Sterilization

[08806390859943]

Moist Heat or Steam Sterilization

[08806390859943]

Moist Heat or Steam Sterilization

[08806390859943]

Moist Heat or Steam Sterilization

[08806390859943]

Moist Heat or Steam Sterilization

[08806390859943]

Moist Heat or Steam Sterilization

[08806390859943]

Moist Heat or Steam Sterilization

[08806390859943]

Moist Heat or Steam Sterilization

[08806390859943]

Moist Heat or Steam Sterilization

[08806390859943]

Moist Heat or Steam Sterilization

[08806390859943]

Moist Heat or Steam Sterilization

[08806390859943]

Moist Heat or Steam Sterilization

[08806390859943]

Moist Heat or Steam Sterilization

[08806390859943]

Moist Heat or Steam Sterilization

[08806390859943]

Moist Heat or Steam Sterilization

[08806390859943]

Moist Heat or Steam Sterilization

[08806390859943]

Moist Heat or Steam Sterilization

[08806390859943]

Moist Heat or Steam Sterilization

[08806390859943]

Moist Heat or Steam Sterilization

[08806390859943]

Moist Heat or Steam Sterilization

[08806390859943]

Moist Heat or Steam Sterilization

[08806390859943]

Moist Heat or Steam Sterilization

[08806390859943]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2024-06-11
• Device Publish Date: 2017-10-26

On-Brand Devices [VERUM Ankle System Bone Plate]

• 08806390860024: PA1180
• 08806390860017: PA1170
• 08806390860000: PA1160
• 08806390859998: PA1150
• 08806390859981: PA1140
• 08806390859974: PA1130
• 08806390859967: PA1120
• 08806390859950: PA1110
• 08806390859943: PA1100
• 08806390859936: PA1090
• 08806390859929: PA1080
• 08806390859912: PA1070
• 08806390859905: PA1060
• 08806390859899: PA1050
• 08806390859882: PA1040
• 08806390859875: PA1030
• 08806390859868: PA1020
• 08806390859851: PA1010