GUDID 06009544002307

Chrome Cobalt Abutment, Non-Engaging, for Ø4.0 Ex Hex

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: 06009544002307
• NIH Device Record Key: 6da0d184-87a4-4a6e-98d1-98b9ebcb9a02
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: CC-NX-40
• 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	06009544002307 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163634

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[06009544002307]

Moist Heat or Steam Sterilization

[06009544002307]

Moist Heat or Steam Sterilization

[06009544002307]

Moist Heat or Steam Sterilization

[06009544002307]

Moist Heat or Steam Sterilization

[06009544002307]

Moist Heat or Steam Sterilization

[06009544002307]

Moist Heat or Steam Sterilization

[06009544002307]

Moist Heat or Steam Sterilization

[06009544002307]

Moist Heat or Steam Sterilization

[06009544002307]

Moist Heat or Steam Sterilization

[06009544002307]

Moist Heat or Steam Sterilization

[06009544002307]

Moist Heat or Steam Sterilization

[06009544002307]

Moist Heat or Steam Sterilization

[06009544002307]

Moist Heat or Steam Sterilization

[06009544002307]

Moist Heat or Steam Sterilization

[06009544002307]

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: 2019-01-17

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• 06009544045311 - N/A: 2024-06-07 Implant Inverta MSc DC30 Ø3.75x15
• 06009544045328 - N/A: 2024-06-07 Implant Inverta MSc DC35 Ø4.5x8