SPI VARIO

GUDID 07640156472523

Thommen Medical AG

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07640156472523
• NIH Device Record Key: f830acd7-8fa3-4ed0-985c-2aee186beea3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPI VARIO
• Version Model Number: 4.03.685
• Company DUNS: 481614829
• Company Name: Thommen Medical AG
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640156472523 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101798

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07640156472523]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-10-24

On-Brand Devices [SPI VARIO]

• 07640156476262: 2.03.400
• 07640156476255: 2.03.401
• 07640156476248: 2.03.402
• 07640156476231: 2.03.403
• 07640156476224: 2.03.404
• 07640156476217: 2.03.410
• 07640156476200: 2.03.411
• 07640156476194: 2.03.412
• 07640156476187: 2.03.413
• 07640156476170: 2.03.414
• 07640156476149: 2.03.600
• 07640156473360: 4.03.600
• 07640156473353: 4.03.601
• 07640156473346: 4.03.602
• 07640156473339: 4.03.603
• 07640156473322: 4.03.605
• 07640156473315: 4.03.606
• 07640156473308: 4.03.607
• 07640156473292: 4.03.608
• 07640156473285: 4.03.610
• 07640156473278: 4.03.611
• 07640156473261: 4.03.612
• 07640156473254: 4.03.613
• 07640156473247: 4.03.680
• 07640156473230: 4.03.681
• 07640156473223: 4.03.682
• 07640156472523: 4.03.685
• 07640156472516: 4.03.686
• 07640156472509: 4.03.687
• 07640156472493: 2.03.610
• 07640156472240: 1.03.160
• 07640156472233: 1.03.161
• 07640156472226: 1.03.162
• 07640156472219: 1.03.163
• 07640156472202: 1.03.180
• 07640156472196: 1.03.181
• 07640156472189: 1.03.182
• 07640156472172: 1.03.183
• 07640156472158: 4.03.683
• 07640156472141: 4.03.684
• 07640156472134: 4.03.688
• 07640156472127: 4.03.689