SICAT OPTISLEEP 10401

GUDID D776104010

SiCAT GmbH & Co. KG

Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: D776104010
• NIH Device Record Key: a733fc19-71e4-44d2-93a6-acca99ef8f53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SICAT OPTISLEEP
• Version Model Number: 10401
• Catalog Number: 10401
• 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: true
• 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

Customer Support Contacts

• Phone: +4922885469712
• Email: sgl@sicat.com
• Phone: +4922885469712
• Email: sgl@sicat.com
• Phone: +4922885469712
• Email: sgl@sicat.com
• Phone: +4922885469712
• Email: sgl@sicat.com
• Phone: +4922885469712
• Email: sgl@sicat.com
• Phone: +4922885469712
• Email: sgl@sicat.com
• Phone: +4922885469712
• Email: sgl@sicat.com
• Phone: +4922885469712
• Email: sgl@sicat.com
• Phone: +4922885469712
• Email: sgl@sicat.com
• Phone: +4922885469712
• Email: sgl@sicat.com
• Phone: +4922885469712
• Email: sgl@sicat.com
• Phone: +4922885469712
• Email: sgl@sicat.com
• Phone: +4922885469712
• Email: sgl@sicat.com
• Phone: +4922885469712
• Email: sgl@sicat.com
• Phone: +4922885469712
• Email: sgl@sicat.com
• Phone: +4922885469712
• Email: sgl@sicat.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D776104010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153291

FDA Product Code

• LRK: Device, Anti-Snoring

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-31

On-Brand Devices [SICAT OPTISLEEP]

• D776104010: 10401
• D776OSLEEPV11: V1.1
• D776OSLEEPV110: V1.1