ST Temporalis

GUDID 00866453000147

Silicone Temporal Implant - Large

Osteosymbionics, LLC

Chin prosthesis

• Primary Device ID: 00866453000147
• NIH Device Record Key: ed81a1ae-18f5-4d47-b0b9-35968914abc2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ST Temporalis
• Version Model Number: STT-60
• Company DUNS: 858769651
• Company Name: Osteosymbionics, LLC
• Device Count: 1
• DM Exempt: true
• 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	00866453000147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111069

FDA Product Code

• MNF: Implant, Temporal

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: 2015-10-26

On-Brand Devices [ST Temporalis]

• 00866453000147: Silicone Temporal Implant - Large
• 00866453000130: Silicone Temporal Implant - Small