GUDID 06009544017950

Titanium Cylinder for Ø4.3 Tri-Nex Passive Abutment, Engaging

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 06009544017950
• NIH Device Record Key: 4b784dc7-5b18-4f37-b07b-8c2f506d96be
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: PA-EL-43TC
• 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	06009544017950 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070905

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[06009544017950]

Moist Heat or Steam Sterilization

[06009544017950]

Moist Heat or Steam Sterilization

[06009544017950]

Moist Heat or Steam Sterilization

[06009544017950]

Moist Heat or Steam Sterilization

[06009544017950]

Moist Heat or Steam Sterilization

[06009544017950]

Moist Heat or Steam Sterilization

[06009544017950]

Moist Heat or Steam Sterilization

[06009544017950]

Moist Heat or Steam Sterilization

[06009544017950]

Moist Heat or Steam Sterilization

[06009544017950]

Moist Heat or Steam Sterilization

[06009544017950]

Moist Heat or Steam Sterilization

[06009544017950]

Moist Heat or Steam Sterilization

[06009544017950]

Moist Heat or Steam Sterilization

[06009544017950]

Moist Heat or Steam Sterilization

[06009544017950]

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

• 06009544048671 - NA: 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x30mm
• 06009544048688 - NA: 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x32.5mm
• 06009544048695 - NA: 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x35mm
• 06009544048701 - NA: 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x37.5mm
• 06009544048718 - NA: 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x40mm
• 06009544048725 - NA: 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x42.5mm
• 06009544048732 - NA: 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x45mm
• 06009544048749 - NA: 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x47.5mm