SICAT OPTISLEEP 10401
GUDID D776104010
SiCAT GmbH & Co. KG
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 |
| sgl@sicat.com | |
| Phone | +4922885469712 |
| sgl@sicat.com | |
| Phone | +4922885469712 |
| sgl@sicat.com | |
| Phone | +4922885469712 |
| sgl@sicat.com | |
| Phone | +4922885469712 |
| sgl@sicat.com | |
| Phone | +4922885469712 |
| sgl@sicat.com | |
| Phone | +4922885469712 |
| sgl@sicat.com | |
| Phone | +4922885469712 |
| sgl@sicat.com | |
| Phone | +4922885469712 |
| sgl@sicat.com | |
| Phone | +4922885469712 |
| sgl@sicat.com | |
| Phone | +4922885469712 |
| sgl@sicat.com | |
| Phone | +4922885469712 |
| sgl@sicat.com | |
| Phone | +4922885469712 |
| sgl@sicat.com | |
| Phone | +4922885469712 |
| sgl@sicat.com | |
| Phone | +4922885469712 |
| sgl@sicat.com | |
| Phone | +4922885469712 |
| 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 |
Trademark Results [SICAT OPTISLEEP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SICAT OPTISLEEP 79156825 4857226 Live/Registered |
SiCAT GmbH & Co. KG 2014-09-26 |
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