GUDID 06009544001393

Ext. Hex Tapered Implant, Int. Drive, Ø5.0 x 15mm

SOUTHERN IMPLANTS (PTY) LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 06009544001393
• NIH Device Record Key: aec69c1b-7e48-4019-98e1-bcae9c0d99de
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BATI15
• 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	06009544001393 [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: 2019-02-11
• Device Publish Date: 2019-01-11

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