GUDID 06009544013631

Instrument Tray for Tri-Nex

SOUTHERN IMPLANTS (PTY) LTD

Instrument tray

• Primary Device ID: 06009544013631
• NIH Device Record Key: 34da0660-4d09-4921-934f-5c56f36b66b5
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: I-TRI-NEX-EG
• Company DUNS: 636239584
• Company Name: SOUTHERN IMPLANTS (PTY) LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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	06009544013631 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210923

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-01
• Device Publish Date: 2018-12-01

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

• 06009544027638 - N/A: 2025-04-10 Resorbable collagen membrane 15x20mm
• 06009544027645 - N/A: 2025-04-10 Resorbable collagen membrane 20x30mm
• 06009544027652 - N/A: 2025-04-10 Resorbable collagen membrane 30x40mm
• 06009544027669 - N/A: 2025-04-10 Bone matrix, porcine cancellous fine 0.5cc
• 06009544027676 - N/A: 2025-04-10 Bone matrix, porcine cancellous fine 1.0cc
• 06009544027683 - N/A: 2025-04-10 Bone matrix, porcine cancellous fine 2.0cc
• 06009544027690 - N/A: 2025-04-10 Bone matrix, porcine cancellous std 2.0cc
• 06009544027706 - N/A: 2025-04-10 Bone matrix, porcine cancellous std 1.0cc