Tri-Nex

GUDID 06009544009726

Tri-Nex Cylindrical Implant, Ø5.0 x 8.6mm

SOUTHERN IMPLANTS (PTY) LTD

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• Primary Device ID: 06009544009726
• NIH Device Record Key: 2415ec66-212d-4122-b0c9-fc1517f77eb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tri-Nex
• Version Model Number: IA-LHS-50-8
• Company DUNS: 636239584
• Company Name: SOUTHERN IMPLANTS (PTY) LTD
• 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: false
• Expiration Date: true
• 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	06009544009726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070905

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-08
• Device Publish Date: 2019-01-08

On-Brand Devices [Tri-Nex]

• 06009544009726: Tri-Nex Cylindrical Implant, Ø5.0 x 8.6mm
• 06009544009719: Tri-Nex Cylindrical Implant, Ø5.0 x 15.5mm
• 06009544009702: Tri-Nex Cylindrical Implant, Ø5.0 x 13.5mm
• 06009544009696: Tri-Nex Cylindrical Implant, Ø5.0 x 12mm
• 06009544009689: Tri-Nex Cylindrical Implant, Ø5.0 x 10.5mm
• 06009544009672: Tri-Nex Cylindrical Implant, Ø4.3 x 8.6mm
• 06009544009665: Tri-Nex Cylindrical Implant, Ø4.3 x 15.5mm
• 06009544009658: Tri-Nex Cylindrical Implant, Ø4.3 x 13.5mm
• 06009544009641: Tri-Nex Cylindrical Implant, Ø4.3 x 12mm
• 06009544009634: Tri-Nex Cylindrical Implant, Ø4.3 x 10.5mm
• 06009544009627: Tri-Nex Cylindrical Implant, Ø3.5 x 8.5mm
• 06009544009610: Tri-Nex Cylindrical Implant, Ø3.5 x 15.5mm
• 06009544009603: Tri-Nex Cylindrical Implant, Ø3.5 x 13.5mm
• 06009544009597: Tri-Nex Cylindrical Implant, Ø3.5 x 12mm
• 06009544009580: Tri-Nex Cylindrical Implant, Ø3.5 x 10.5mm
• 06009544009573: Tri-Nex Tapered Implant, Ø6.0 x 8.6mm
• 06009544009566: Tri-Nex Tapered Implant, Ø6.0 x 16.5mm
• 06009544009559: Tri-Nex Tapered Implant, Ø6.0 x 13.5mm
• 06009544009542: Tri-Nex Tapered Implant, Ø6.0 x 12mm
• 06009544009535: Tri-Nex Tapered Implant, Ø6.0 x 10.5mm
• 06009544009528: Tri-Nex Tapered Implant, Ø5.0 x 8.6mm
• 06009544009511: Tri-Nex Tapered Implant, Ø5.0 x 16.5mm
• 06009544009504: Tri-Nex Tapered Implant, Ø5.0 x 13.5mm
• 06009544009498: Tri-Nex Tapered Implant, Ø5.0 x 12mm
• 06009544009481: Tri-Nex Tapered Implant, Ø5.0 x 10.5mm
• 06009544009474: Tri-Nex Tapered Implant, Ø4.3 x 8.6mm
• 06009544009467: Tri-Nex Tapered Implant, Ø4.3 x 16.5mm
• 06009544009450: Tri-Nex Tapered Implant, Ø4.3 x 13.5mm
• 06009544009443: Tri-Nex Tapered Implant, Ø4.3 x 12mm
• 06009544009436: Tri-Nex Tapered Implant, Ø4.3 x 10.5mm
• 06009544009429: Tri-Nex Tapered Implant, Ø3.5 x 8.5mm
• 06009544009412: Tri-Nex Tapered Implant, Ø3.5 x 16.5mm
• 06009544009405: Tri-Nex Tapered Implant, Ø3.5 x 13.5mm
• 06009544009399: Tri-Nex Tapered Implant, Ø3.5 x 12mm
• 06009544009382: Tri-Nex Tapered Implant, Ø3.5 x 10.5mm