SPI CONTACT INICELL

GUDID 07640156470512

Thommen Medical AG

Screw endosteal dental implant, two-piece

• Primary Device ID: 07640156470512
• NIH Device Record Key: e3e2e62f-f03d-45d7-9906-ffab1e6e449a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPI CONTACT INICELL
• Version Model Number: 4.23.637
• 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: true
• 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	07640156470512 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090154

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

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 CONTACT INICELL]

• 07640156471090: 4.23.214
• 07640156471083: 4.23.215
• 07640156471076: 4.23.216
• 07640156471069: 4.23.223
• 07640156471052: 4.23.224
• 07640156471045: 4.23.225
• 07640156471038: 4.23.226
• 07640156471021: 4.23.233
• 07640156471014: 4.23.234
• 07640156471007: 4.23.235
• 07640156470994: 4.23.236
• 07640156470987: 4.23.237
• 07640156470970: 4.23.243
• 07640156470963: 4.23.244
• 07640156470956: 4.23.245
• 07640156470949: 4.23.246
• 07640156470932: 4.23.247
• 07640156470925: 4.23.253
• 07640156470918: 4.23.254
• 07640156470901: 4.23.255
• 07640156470895: 4.23.256
• 07640156470710: 4.23.615
• 07640156470697: 4.23.616
• 07640156470673: 4.23.617
• 07640156470659: 4.23.624
• 07640156470635: 4.23.625
• 07640156470611: 4.23.626
• 07640156470598: 4.23.627
• 07640156470574: 4.23.634
• 07640156470550: 4.23.635
• 07640156470536: 4.23.636
• 07640156470512: 4.23.637
• 07640156470499: 4.23.644
• 07640156470475: 4.23.645
• 07640156470451: 4.23.646
• 07640156470437: 4.23.647
• 07640156470413: 4.23.654
• 07640156470390: 4.23.655
• 07640156470376: 4.23.656
• 07640156470352: 4.23.657