SICAT IMPLANT

GUDID D776IMPLANTV200

SiCAT GmbH & Co. KG

Radiology PACS software

• Primary Device ID: D776IMPLANTV200
• NIH Device Record Key: 3102adb7-a3e5-4029-9a5f-a4caab9ceefd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SICAT IMPLANT
• Version Model Number: V2.0
• Company DUNS: 333707003
• Company Name: SiCAT GmbH & Co. KG
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D776IMPLANTV200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192348

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-20
• Device Publish Date: 2019-12-12

On-Brand Devices [SICAT IMPLANT]

• D776IMPLANTV15: V1.5
• D776IMPLANTV200: V2.0
• D776IMPLANTV150: V1.5
• D776IMPLANTV20400: V2.0.40