Leforte System Bone Screw / GBR System Bone Screw

GUDID 08809265155089

Jeil Medical Corporation

Craniofacial bone screw, non-bioabsorbable

• Primary Device ID: 08809265155089
• NIH Device Record Key: 389f2462-8f47-43e5-a91f-27af9640d0d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leforte System Bone Screw / GBR System Bone Screw
• Version Model Number: 16-AT-003
• 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	08809265155089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091686

FDA Product Code

• DZL: Screw, Fixation, Intraosseous

Sterilization

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

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

[08809265155089]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2023-09-18
• Device Publish Date: 2015-09-24

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

• 08809265155201: 20-AT-012
• 08809265155195: 20-AT-010
• 08809265155188: 20-AT-008
• 08809265155171: 20-AT-006
• 08809265155164: 20-AT-005
• 08809265155157: 20-AT-004
• 08809265155140: 16-AT-012
• 08809265155133: 16-AT-010
• 08809265155126: 16-AT-008
• 08809265155119: 16-AT-006
• 08809265155102: 16-AT-005
• 08809265155096: 16-AT-004
• 08809265155089: 16-AT-003
• 08809265155072: 14-AT-012
• 08809265155065: 14-AT-010
• 08809265155058: 14-AT-008
• 08809265155041: 14-AT-006
• 08809265155034: 14-AT-005
• 08809265155027: 14-AT-004
• 08809265155010: 14-AT-003
• 08806390805650: 14-AT-012
• 08806390805643: 14-AT-010
• 08806390805636: 14-AT-008
• 08806390805629: 14-AT-006
• 08806390805612: 14-AT-004
• 08806390800242: 16-AT-007