GUDID 06009544007111

35° Angled Abutment for Ø5.0 Ex Hex

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 06009544007111
• NIH Device Record Key: 2103befb-376f-469f-961b-3f98a0b03ca5
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: GB35
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	06009544007111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003620

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[06009544007111]

Moist Heat or Steam Sterilization

[06009544007111]

Moist Heat or Steam Sterilization

[06009544007111]

Moist Heat or Steam Sterilization

[06009544007111]

Moist Heat or Steam Sterilization

[06009544007111]

Moist Heat or Steam Sterilization

[06009544007111]

Moist Heat or Steam Sterilization

[06009544007111]

Moist Heat or Steam Sterilization

[06009544007111]

Moist Heat or Steam Sterilization

[06009544007111]

Moist Heat or Steam Sterilization

[06009544007111]

Moist Heat or Steam Sterilization

[06009544007111]

Moist Heat or Steam Sterilization

[06009544007111]

Moist Heat or Steam Sterilization

[06009544007111]

Moist Heat or Steam Sterilization

[06009544007111]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-01-23

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

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• 06009544048619 - N/A: 2024-09-03 Implant SP1 Ø4.0x15mm
• 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