GUDID 06009544042792

Torx Titanium Screw for Ø5.0 DC, Angulated Screw Channel

SOUTHERN IMPLANTS (PTY) LTD

Dental prosthesis/implant abutment screw

• Primary Device ID: 06009544042792
• NIH Device Record Key: eb6ca847-9dd4-4531-b71c-119f18b8a295
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: TS-DC5-ASC
• Company DUNS: 636239584
• Company Name: SOUTHERN IMPLANTS (PTY) LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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	06009544042792 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230873

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-07
• Device Publish Date: 2023-08-30

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