Maxit™

GUDID 06009544016267

Internal Octagon Implant, Ø6.5 Platform, Maxit™, Ø8.0 x 7mm

SOUTHERN IMPLANTS (PTY) LTD

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• Primary Device ID: 06009544016267
• NIH Device Record Key: d6342ad0-dd71-4ae1-a288-7a18d6eefc06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Maxit™
• Version Model Number: MAXIT8-7F
• 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	06009544016267 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071161

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

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: 2019-02-11
• Device Publish Date: 2019-01-10

On-Brand Devices [Maxit™]

• 06009544016304: Internal Octagon Implant, Ø6.5 Platform, Maxit™, Ø9.0 x 9mm
• 06009544016298: Internal Octagon Implant, Ø6.5 Platform, Maxit™, Ø9.0 x 7mm
• 06009544016281: Internal Octagon Implant, Ø6.5 Platform, Maxit™, Ø9.0 x 11mm
• 06009544016274: Internal Octagon Implant, Ø6.5 Platform, Maxit™, Ø8.0 x 9mm
• 06009544016267: Internal Octagon Implant, Ø6.5 Platform, Maxit™, Ø8.0 x 7mm
• 06009544016243: Internal Octagon Implant, Ø4.8 Platform, Maxit™, Ø7.0 x 9mm
• 06009544016236: Internal Octagon Implant, Ø4.8 Platform, Maxit™, Ø7.0 x 7mm
• 06009544016229: Internal Octagon Implant, Ø4.8 Platform, Maxit™, Ø7.0 x 11mm