VERUM System Bone Screw

GUDID 08806390855631

Jeil Medical Corporation

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 08806390855631
• NIH Device Record Key: edd2bd6e-297b-4ad7-9839-86c7aa013fb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERUM System Bone Screw
• Version Model Number: PF3540-L
• 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	08806390855631 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131311

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08806390855631]

Moist Heat or Steam Sterilization

[08806390855631]

Moist Heat or Steam Sterilization

[08806390855631]

Moist Heat or Steam Sterilization

[08806390855631]

Moist Heat or Steam Sterilization

[08806390855631]

Moist Heat or Steam Sterilization

[08806390855631]

Moist Heat or Steam Sterilization

[08806390855631]

Moist Heat or Steam Sterilization

[08806390855631]

Moist Heat or Steam Sterilization

[08806390855631]

Moist Heat or Steam Sterilization

[08806390855631]

Moist Heat or Steam Sterilization

[08806390855631]

Moist Heat or Steam Sterilization

[08806390855631]

Moist Heat or Steam Sterilization

[08806390855631]

Moist Heat or Steam Sterilization

[08806390855631]

Moist Heat or Steam Sterilization

[08806390855631]

Moist Heat or Steam Sterilization

[08806390855631]

Moist Heat or Steam Sterilization

[08806390855631]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2024-06-07
• Device Publish Date: 2017-10-23

On-Brand Devices [VERUM System Bone Screw]

• 08806390859554: PR2530
• 08806390859547: PR2528
• 08806390859530: PR2526
• 08806390859523: PR2524
• 08806390859516: PR2522
• 08806390859509: PR2520
• 08806390859493: PR2518
• 08806390859486: PR2516
• 08806390859479: PR2514
• 08806390859462: PR2512
• 08806390859455: PR2510
• 08806390859448: PR2508
• 08806390859431: PR2530-L
• 08806390859424: PR2528-L
• 08806390859417: PR2526-L
• 08806390859400: PR2524-L
• 08806390859394: PR2522-L
• 08806390859387: PR2520-L
• 08806390859370: PR2518-L
• 08806390859363: PR2516-L
• 08806390859356: PR2514-L
• 08806390859349: PR2512-L
• 08806390859332: PR2510-L
• 08806390859325: PR2508-L
• 08806390858038: PH1506-L
• 08806390858021: CC0240
• 08806390858014: CC0230
• 08806390855341: PF2808-L
• 08806390858199: PH1508-H1
• 08806390858182: PH1507-H1
• 08806390858175: PH1506-H1
• 08806390858144: PH1520-L
• 08806390858137: PH1518-L
• 08806390858120: PH1516-L
• 08806390858113: PH1514-L
• 08806390858106: PH1513-L
• 08806390858090: PH1512-L
• 08806390858083: PH1511-L
• 08806390858076: PH1510-L
• 08806390858069: PH1509-L
• 08806390858052: PH1508-L
• 08806390858045: PH1507-L
• 08806390857895: CC6080-L
• 08806390857888: CC6075-L
• 08806390857871: CC6070-L
• 08806390857864: CC6065-L
• 08806390857857: CC6060-L
• 08806390857840: CC6055-L
• 08806390857833: CC6050-L
• 08806390857826: CC6045-L