GBR System J-TAC

GUDID 08806390822749

Jeil Medical Corporation

Dental regeneration membrane fixation tack, non-bioabsorbable

• Primary Device ID: 08806390822749
• NIH Device Record Key: 481d1c1c-0a3a-4303-b842-915389710563
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GBR System J-TAC
• Version Model Number: JT-CL-030
• Company DUNS: 688811603
• Company Name: Jeil Medical Corporation
• Device Count: 5
• 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	08806390822749 [Primary]
GS1	08806390823296 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101902

FDA Product Code

• DZL: Screw, Fixation, Intraosseous

Sterilization

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

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

[08806390822749]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-12-18
• Device Publish Date: 2016-04-27

On-Brand Devices [GBR System J-TAC]

• 08809265159674: JT-CL-040
• 08809265159667: JT-CL-030
• 08809265159315: JT-MD-045
• 08809265159308: JT-MD-035
• 08806390822756: JT-CL-040
• 08806390822749: JT-CL-030