GUDID 06009544037606

Handpiece Insertion Tool for Ø3.5 Tri-Nex, Guided Surgery

SOUTHERN IMPLANTS (PTY) LTD

Dental implant holding endpiece

• Primary Device ID: 06009544037606
• NIH Device Record Key: 49a81a9c-533a-4719-b189-f8803e8a3cc7
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: I-HLH-35GS
• 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: true
• 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	06009544037606 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

[06009544037606]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-12
• Device Publish Date: 2024-04-04

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

• 06009544026266 - NA: 2025-12-29 Torx Titanium Screw for IT, Angulated Screw Channel
• 06009544050919 - N/A: 2025-12-29 Angulated Screw Channel Abutment, Engaging, for Ø5.0 DC
• 06009544050926 - N/A: 2025-12-29 Angulated Screw Channel Abutment, Engaging, for IT
• 06009544050957 - N/A: 2025-12-26 Guided Surgery Sleeve, OD Ø5.1 / ID Ø4.2 x 4mm
• 06009544050964 - N/A: 2025-12-26 Guided Surgery Sleeve, OD Ø5.2 / ID Ø4.2 x 6mm
• 06009544050971 - N/A: 2025-12-26 Guided Surgery Sleeve, OD Ø6.2 / ID Ø5.2 x 4mm
• 06009544050988 - N/A: 2025-12-26 Guided Surgery Sleeve, OD Ø6.2 / Ø5.2 x 6mm
• 06009544050995 - N/A: 2025-12-26 Guided Surgery Sleeve, OD Ø6.2 / ID Ø5.2 x 4mm, Multipack x5