SPI VARIOeco

GUDID 07640156472028

Thommen Medical AG

Dental implant suprastructure kit

• Primary Device ID: 07640156472028
• NIH Device Record Key: 7d742659-283b-4195-a47b-8fd130fc9a5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPI VARIOeco
• Version Model Number: 1.04.784
• 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	07640156472028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121334

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[07640156472028]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [SPI VARIOeco]

• 07640156472110: 1.04.770
• 07640156472103: 1.04.771
• 07640156472097: 1.04.772
• 07640156472080: 1.04.773
• 07640156472073: 1.04.774
• 07640156472066: 1.04.782
• 07640156472059: 1.04.780
• 07640156472042: 1.04.781
• 07640156472035: 1.04.783
• 07640156472028: 1.04.784