Leforte Neuro System Bone Screw

GUDID 08809282812378

Jeil Medical Corporation

Craniofacial bone screw, non-bioabsorbable

• Primary Device ID: 08809282812378
• NIH Device Record Key: d2661fce-f17a-4b53-826c-10e1f2ac2c77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leforte Neuro System Bone Screw
• Version Model Number: 14-NL-004
• 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	08809282812378 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141452

FDA Product Code

• GWO: Plate, Cranioplasty, Preformed, Alterable

Sterilization

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

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

[08809282812378]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-09-18
• Device Publish Date: 2015-09-24

On-Brand Devices [Leforte Neuro System Bone Screw]

• 08809282812392: 16-NL-004-E
• 08809282812385: 14-NL-005
• 08809282812378: 14-NL-004
• 08809282812361: 14-NL-003
• 08809265155386: 16-NF-004-E
• 08809265155355: 16-NF-005
• 08809265155348: 16-NF-004
• 08809265155331: 16-NF-003
• 08809265155324: 14-NF-005
• 08809265155317: 14-NF-004
• 08809265155300: 14-NF-003
• 08809265155218: 19-NF-004-E