Provata

GUDID 06009544026549

Internal Hex Max Tapered Implant, Ø8.0 x 9mm

SOUTHERN IMPLANTS (PTY) LTD

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• Primary Device ID: 06009544026549
• NIH Device Record Key: 67c03a61-c3c6-49b6-a505-5e9e34366993
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Provata
• Version Model Number: PROMAX809
• 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	06009544026549 [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 [Provata]

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• 06009544026945: Internal Hex Max Tapered Implant, Ø6.0 x 9mm
• 06009544026938: Internal Hex Max Tapered Implant, Ø6.0 x 7mm
• 06009544026808: Internal Hex Tapered Implant, Ø5.0 x 18mm
• 06009544026792: Internal Hex Tapered Implant, Ø5.0 x 15mm
• 06009544026785: Internal Hex Tapered Implant, Ø5.0 x 13mm
• 06009544026778: Internal Hex Tapered Implant, Ø5.0 x 11.5mm
• 06009544026761: Internal Hex Tapered Implant, Ø5.0 x 10mm
• 06009544026754: Internal Hex Tapered Implant, Ø5.0 x 8.5mm
• 06009544026747: Internal Hex Tapered Implant, Ø4.0 x 18mm
• 06009544026730: Internal Hex Tapered Implant, Ø4.0 x 15mm
• 06009544026723: Internal Hex Tapered Implant, Ø4.0 x 13mm
• 06009544026716: Internal Hex Tapered Implant, Ø4.0 x 11.5mm
• 06009544026709: Internal Hex Tapered Implant, Ø4.0 x 10mm
• 06009544026693: Internal Hex Tapered Implant, Ø4.0 x 8.5mm
• 06009544026587: Internal Hex Max Tapered Implant, Ø9.0 x 11mm
• 06009544026570: Internal Hex Max Tapered Implant, Ø9.0 x 9mm
• 06009544026563: Internal Hex Max Tapered Implant, Ø9.0 x 7mm
• 06009544026556: Internal Hex Max Tapered Implant, Ø8.0 x 11mm
• 06009544026549: Internal Hex Max Tapered Implant, Ø8.0 x 9mm
• 06009544026532: Internal Hex Max Tapered Implant, Ø8.0 x 7mm
• 06009544026525: Internal Hex Max Tapered Implant, Ø7.0 x 11mm
• 06009544026518: Internal Hex Max Tapered Implant, Ø7.0 x 9mm
• 06009544026501: Internal Hex Max Tapered Implant, Ø7.0 x 7mm