Co-Axis™

GUDID 06009544024453

Ext. Hex Reduced Platform Implant, 24° Co-Axis™, Ø4.0 x 11.5mm

SOUTHERN IMPLANTS (PTY) LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 06009544024453
• NIH Device Record Key: 85e83f43-a96f-4250-8bdc-33aca7bfb623
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Co-Axis™
• Version Model Number: IBR24D-11.5
• 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	06009544024453 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163634

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: 2019-02-15
• Device Publish Date: 2019-01-15

On-Brand Devices [Co-Axis™]

• 06009544032281: DC Tapered Implant, 12° Co-Axis™, Ø5.0 x 15mm
• 06009544032274: DC Tapered Implant, 12° Co-Axis™, Ø5.0 x 13mm
• 06009544032267: DC Tapered Implant, 12° Co-Axis™, Ø5.0 x 11mm
• 06009544032250: DC Tapered Implant, 12° Co-Axis™, Ø5.0 x 9mm
• 06009544032243: DC Cylindrical Implant, 12° Co-Axis™, Ø5.0 x 15mm
• 06009544032236: DC Cylindrical Implant, 12° Co-Axis™, Ø5.0 x 13mm
• 06009544032229: DC Cylindrical Implant, 12° Co-Axis™, Ø5.0 x 11mm
• 06009544032212: DC Cylindrical Implant, 12° Co-Axis™, Ø5.0 x 9mm
• 06009544028109: Ext. Hex Implant, MSc Reduced Platform, 12° Co-Axis™, Ø4.0 x 18mm
• 06009544027218: Ext. Hex Tapered Implant, 24° Co-Axis™, Ø6.0 x 18mm
• 06009544026488: Ext. Hex Implant, MSc Reduced Platform, 24° Co-Axis™, Ø5.0 x 18mm
• 06009544026471: Ext. Hex Implant, MSc Reduced Platform, 12° Co-Axis™, Ø5.0 x 18mm
• 06009544026464: Ext. Hex Implant, MSc Reduced Platform, 24° Co-Axis™, Ø4.0 x 18mm
• 06009544026457: Ext. Hex Implant, MSc, 12° Co-Axis™, Ø3.25 x 18mm
• 06009544025122: Ext. Hex Implant, MSc Reduced Platform, 24° Co-Axis™, Ø4.0 x 8.5mm
• 06009544025115: Ext. Hex Implant, MSc Reduced Platform, 24° Co-Axis™, Ø4.0 x 15mm
• 06009544025108: Ext. Hex Implant, MSc Reduced Platform, 24° Co-Axis™, Ø4.0 x 13mm
• 06009544025092: Ext. Hex Implant, MSc Reduced Platform, 24° Co-Axis™, Ø4.0 x 11.5mm
• 06009544025085: Ext. Hex Implant, MSc Reduced Platform, 24° Co-Axis™, Ø4.0 x 10mm
• 06009544025078: Ext. Hex Implant, MSc Reduced Platform, 12° Co-Axis™, Ø4.0 x 8.5mm
• 06009544025061: Ext. Hex Implant, MSc Reduced Platform, 12° Co-Axis™, Ø4.0 x 15mm
• 06009544025054: Ext. Hex Implant, MSc Reduced Platform, 12° Co-Axis™, Ø4.0 x 13mm
• 06009544025047: Ext. Hex Implant, MSc Reduced Platform, 12° Co-Axis™, Ø4.0 x 11.5mm
• 06009544025030: Ext. Hex Implant, MSc Reduced Platform, 12° Co-Axis™, Ø4.0 x 10mm
• 06009544024972: Ext. Hex Implant, MSc Reduced Platform, 24° Co-Axis™, Ø5.0 x 8.5mm
• 06009544024965: Ext. Hex Implant, MSc Reduced Platform, 24° Co-Axis™, Ø5.0 x 15mm
• 06009544024958: Ext. Hex Implant, MSc Reduced Platform, 24° Co-Axis™, Ø5.0 x 13mm
• 06009544024941: Ext. Hex Implant, MSc Reduced Platform, 24° Co-Axis™, Ø5.0 x 11.5mm
• 06009544024934: Ext. Hex Implant, MSc Reduced Platform, 24° Co-Axis™, Ø5.0 x 10mm
• 06009544024927: Ext. Hex Implant, MSc Reduced Platform, 12° Co-Axis™, Ø5.0 x 8.5mm
• 06009544024910: Ext. Hex Implant, MSc Reduced Platform, 12° Co-Axis™, Ø5.0 x 15mm
• 06009544024903: Ext. Hex Implant, MSc Reduced Platform, 12° Co-Axis™, Ø5.0 x 13mm
• 06009544024897: Ext. Hex Implant, MSc Reduced Platform, 12° Co-Axis™, Ø5.0 x 11.5mm
• 06009544024880: Ext. Hex Implant, MSc Reduced Platform, 12° Co-Axis™, Ø5.0 x 10mm
• 06009544024521: Ext. Hex Reduced Platform Implant, 24° Co-Axis™, Ø4.0 x 8.5mm
• 06009544024491: Ext. Hex Reduced Platform Implant, 24° Co-Axis™, Ø4.0 x 20mm
• 06009544024484: Ext. Hex Reduced Platform Implant, 24° Co-Axis™, Ø4.0 x 18mm
• 06009544024477: Ext. Hex Reduced Platform Implant, 24° Co-Axis™, Ø4.0 x 15mm
• 06009544024460: Ext. Hex Reduced Platform Implant, 24° Co-Axis™, Ø4.0 x 13mm
• 06009544024453: Ext. Hex Reduced Platform Implant, 24° Co-Axis™, Ø4.0 x 11.5mm
• 06009544024446: Ext. Hex Reduced Platform Implant, 24° Co-Axis™, Ø4.0 x 10mm
• 06009544024439: Ext. Hex Reduced Platform Implant, 12° Co-Axis™, Ø4.0 x 8.5mm
• 06009544024422: Ext. Hex Reduced Platform Implant, 12° Co-Axis™, Ø4.0 x 18mm
• 06009544024415: Ext. Hex Reduced Platform Implant, 12° Co-Axis™, Ø4.0 x 15mm
• 06009544024408: Ext. Hex Reduced Platform Implant, 12° Co-Axis™, Ø4.0 x 13mm
• 06009544024392: Ext. Hex Reduced Platform Implant, 12° Co-Axis™, Ø4.0 x 11.5mm
• 06009544024385: Ext. Hex Reduced Platform Implant, 12° Co-Axis™, Ø4.0 x 10mm
• 06009544024378: Ext. Hex Tapered Implant, 12° Co-Axis™, Ø3.25 x 8.5mm
• 06009544024361: Ext. Hex Tapered Implant, 12° Co-Axis™, Ø3.25 x 18mm
• 06009544024354: Ext. Hex Tapered Implant, 12° Co-Axis™, Ø3.25 x 15mm