GALILEOS Implant 6143205

GUDID D776GIV1920

SiCAT GmbH & Co. KG

Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software

• Primary Device ID: D776GIV1920
• NIH Device Record Key: b9cd9d71-e50e-4520-93d0-973df152609f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GALILEOS Implant
• Version Model Number: 1.9.2
• Catalog Number: 6143205
• 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: false
• Serial Number: true
• 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	D776GIV1920 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093090

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: 2019-08-15
• Device Publish Date: 2019-08-07

Devices Manufactured by SiCAT GmbH & Co. KG

• D776SBPV100 - SICAT Bite Plate: 2024-03-05 SICAT Bite Plate
• D776OSLEEPV110 - SICAT OPTISLEEP: 2023-08-11
• D776103000 - SICAT Bite Plate (Kit): 2023-06-21 SICAT Bite Plate Kit
• D776OSLEEPV11 - SICAT OPTISLEEP: 2022-10-31
• D776105010 - SICAT OPTIMOTION: 2022-08-15 SICAT OPTIMOTION
• D776106010 - SICAT ACCESSGUIDE: 2022-08-15 SICAT ACCESSGUIDE
• D776103010 - SICAT SURGICAL GUIDE: 2022-08-12 SICAT SURGICAL GUIDE
• D776AIRV20400 - SICAT Air: 2022-01-20