GUDID 06009544008910

Healing Abutment for Ø4.3 Tri-Nex, Ø4.5 x 7mm

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 06009544008910
• NIH Device Record Key: 8e4d4fa0-da14-42b1-8618-6fd65aa54e41
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: HA-L-43-7
• 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	06009544008910 [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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-07
• Device Publish Date: 2019-01-07

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