GUDID 06009544044116

Instrument Tray SP1 GS10-16mm

SOUTHERN IMPLANTS (PTY) LTD

Instrument tray, reusable

• Primary Device ID: 06009544044116
• NIH Device Record Key: 9715a468-cedf-40b7-b4fa-7f92800ebfe6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: I-SP-GS2-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	06009544044116 [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

[06009544044116]

Moist Heat or Steam Sterilization

[06009544044116]

Moist Heat or Steam Sterilization

[06009544044116]

Moist Heat or Steam Sterilization

[06009544044116]

Moist Heat or Steam Sterilization

[06009544044116]

Moist Heat or Steam Sterilization

[06009544044116]

Moist Heat or Steam Sterilization

[06009544044116]

Moist Heat or Steam Sterilization

[06009544044116]

Moist Heat or Steam Sterilization

[06009544044116]

Moist Heat or Steam Sterilization

[06009544044116]

Moist Heat or Steam Sterilization

[06009544044116]

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

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

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• 06009544048626 - N/A: 2024-09-03 Implant SP1 Ø4.0x18mm
• 06009544048633 - N/A: 2024-09-03 Implant SP1 Ø4.0x20mm
• 06009544048640 - N/A: 2024-09-03 Implant SP1 Ø4.0x22mm
• 06009544048657 - N/A: 2024-09-03 Implant SP1 Ø4.0x24mm
• 06009544039785 - N/A: 2024-08-30 Cortical Perforator Drill for Guided Surgery ø4.1