GBR System Bone Screw

GUDID 08806390801218

Jeil Medical Corporation

Orthodontic anchoring screw

• Primary Device ID: 08806390801218
• NIH Device Record Key: 1b4e4ce4-999c-48b1-a427-e99d1f5d538d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GBR System Bone Screw
• Version Model Number: 14-AT-008G
• 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	08806390801218 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143730

FDA Product Code

• DZL: Screw, Fixation, Intraosseous

Sterilization

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

[08806390801218]

Moist Heat or Steam Sterilization

[08806390801218]

Moist Heat or Steam Sterilization

[08806390801218]

Moist Heat or Steam Sterilization

[08806390801218]

Moist Heat or Steam Sterilization

[08806390801218]

Moist Heat or Steam Sterilization

[08806390801218]

Moist Heat or Steam Sterilization

[08806390801218]

Moist Heat or Steam Sterilization

[08806390801218]

Moist Heat or Steam Sterilization

[08806390801218]

Moist Heat or Steam Sterilization

[08806390801218]

Moist Heat or Steam Sterilization

[08806390801218]

Moist Heat or Steam Sterilization

[08806390801218]

Moist Heat or Steam Sterilization

[08806390801218]

Moist Heat or Steam Sterilization

[08806390801218]

Moist Heat or Steam Sterilization

[08806390801218]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-01-03
• Device Publish Date: 2015-09-24

On-Brand Devices [GBR System Bone Screw]

• 08809282812088: 16-TT-010
• 08809282812071: 14-AT-005G-25
• 08809282812064: 14-AT-004G-25
• 08809282812057: 14-AT-003G-25
• 08809282812040: 14-AT-005G
• 08809282812033: 14-AT-004G
• 08809282812026: 14-AT-003G
• 08806390801232: 14-AT-012G
• 08806390801225: 14-AT-010G
• 08806390801218: 14-AT-008G
• 08806390801201: 14-AT-006G