GBR System J-TAC

GUDID 08809265159674

Jeil Medical Corporation

Dental regeneration membrane fixation tack, non-bioabsorbable

• Primary Device ID: 08809265159674
• NIH Device Record Key: 3267b022-5b0b-4f1c-a1ed-dde0cf13ceea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GBR System J-TAC
• Version Model Number: JT-CL-040
• 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	08809265159674 [Primary]

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

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

Moist Heat or Steam Sterilization

[08809265159674]

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: 2015-09-24

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