GUDID 06009544044123

Instrument Tray SP1 GS 8-13mm

SOUTHERN IMPLANTS (PTY) LTD

Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable

• Primary Device ID: 06009544044123
• NIH Device Record Key: 74bb7dc1-9db1-425e-b37b-db25732be3a9
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: I-SP-GS1-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	06009544044123 [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

[06009544044123]

Moist Heat or Steam Sterilization

[06009544044123]

Moist Heat or Steam Sterilization

[06009544044123]

Moist Heat or Steam Sterilization

[06009544044123]

Moist Heat or Steam Sterilization

[06009544044123]

Moist Heat or Steam Sterilization

[06009544044123]

Moist Heat or Steam Sterilization

[06009544044123]

Moist Heat or Steam Sterilization

[06009544044123]

Moist Heat or Steam Sterilization

[06009544044123]

Moist Heat or Steam Sterilization

[06009544044123]

Moist Heat or Steam Sterilization

[06009544044123]

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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• 06009544039587 - N/A: 2024-04-03 Implant DC, Ø4.0 x 22mm
• 06009544039594 - N/A: 2024-04-03 Implant DC, Ø4.0 x 24mm
• 06009544046479 - N/A: 2024-04-01 Angulated Screw Channel Abutment, Engaging, for SP1