Leforte System Bone Plate / GBR System Bone Plate

GUDID 08809265150503

Jeil Medical Corporation

Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized

• Primary Device ID: 08809265150503
• NIH Device Record Key: 26c4237a-68b9-4d32-a3e0-d318f1d1a1b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leforte System Bone Plate / GBR System Bone Plate
• Version Model Number: 12-GM-001-02
• 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	08809265150503 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103778

FDA Product Code

• JEY: Plate, Bone

Sterilization

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

[08809265150503]

Moist Heat or Steam Sterilization

[08809265150503]

Moist Heat or Steam Sterilization

[08809265150503]

Moist Heat or Steam Sterilization

[08809265150503]

Moist Heat or Steam Sterilization

[08809265150503]

Moist Heat or Steam Sterilization

[08809265150503]

Moist Heat or Steam Sterilization

[08809265150503]

Moist Heat or Steam Sterilization

[08809265150503]

Moist Heat or Steam Sterilization

[08809265150503]

Moist Heat or Steam Sterilization

[08809265150503]

Moist Heat or Steam Sterilization

[08809265150503]

Moist Heat or Steam Sterilization

[08809265150503]

Moist Heat or Steam Sterilization

[08809265150503]

Moist Heat or Steam Sterilization

[08809265150503]

Moist Heat or Steam Sterilization

[08809265150503]

Moist Heat or Steam Sterilization

[08809265150503]

Moist Heat or Steam Sterilization

[08809265150503]

Moist Heat or Steam Sterilization

[08809265150503]

Moist Heat or Steam Sterilization

[08809265150503]

Moist Heat or Steam Sterilization

[08809265150503]

Moist Heat or Steam Sterilization

[08809265150503]

Moist Heat or Steam Sterilization

[08809265150503]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2021-02-05
• Device Publish Date: 2015-09-24

On-Brand Devices [Leforte System Bone Plate / GBR System Bone Plate]

• 08809282819049: 12-GM-002-01
• 08809265154464: 12-GM-002-02
• 08809265150503: 12-GM-001-02
• 08809265150497: 12-GM-001-01
• 08809265150480: 12-ME-003-05
• 08809265150466: 12-ME-003-03
• 08809265150459: 12-ME-003-02
• 08809265150442: 12-ME-003-01
• 08809265150411: 12-ME-002-03
• 08809265150404: 12-ME-002-02
• 08809265150398: 12-ME-002-01
• 08809265150381: 12-ME-001-05
• 08809265150374: 12-ME-001-04
• 08809265150367: 12-ME-001-03
• 08809265150350: 12-ME-001-02
• 08809265150343: 12-ME-001-01