GUDID 06009544045458

Instrument Tray Extra Oral

SOUTHERN IMPLANTS (PTY) LTD

Instrument tray, reusable

• Primary Device ID: 06009544045458
• NIH Device Record Key: c5105d3d-a7b8-48bb-b6f9-1c8cc7edbe33
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: I-EO-EG
• 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: 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	06009544045458 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210923

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

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

[06009544045458]

Moist Heat or Steam Sterilization

[06009544045458]

Moist Heat or Steam Sterilization

[06009544045458]

Moist Heat or Steam Sterilization

[06009544045458]

Moist Heat or Steam Sterilization

[06009544045458]

Moist Heat or Steam Sterilization

[06009544045458]

Moist Heat or Steam Sterilization

[06009544045458]

Moist Heat or Steam Sterilization

[06009544045458]

Moist Heat or Steam Sterilization

[06009544045458]

Moist Heat or Steam Sterilization

[06009544045458]

Moist Heat or Steam Sterilization

[06009544045458]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-11
• Device Publish Date: 2024-03-01

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• 06009544050605 - N/A: 2025-08-19 Implant DR SP1 Ø3.7x13mm
• 06009544050612 - N/A: 2025-08-19 Implant DR SP1 Ø3.7x16mm
• 06009544050629 - N/A: 2025-08-19 Implant DR SP1 Ø3.7x18mm
• 06009544050636 - N/A: 2025-08-19 Implant DR SP1 Ø3.7x20mm
• 06009544050650 - N/A: 2025-08-19 Implant DR SP1 Ø4.5x8mm