| Primary Device ID | D776103010 |
| NIH Device Record Key | d1496990-78e4-4347-a24f-62f5a1af22d9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SICAT SURGICAL GUIDE |
| Version Model Number | 10301 |
| Catalog Number | 10301 |
| Company DUNS | 333707003 |
| Company Name | SiCAT GmbH & Co. KG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 |
| Phone | +49228286206600 |
| sgl@sicat.com | |
| Phone | +49228286206600 |
| sgl@sicat.com | |
| Phone | +49228286206600 |
| sgl@sicat.com | |
| Phone | +49228286206600 |
| sgl@sicat.com | |
| Phone | +49228286206600 |
| sgl@sicat.com | |
| Phone | +49228286206600 |
| sgl@sicat.com | |
| Phone | +49228286206600 |
| sgl@sicat.com | |
| Phone | +49228286206600 |
| sgl@sicat.com | |
| Phone | +49228286206600 |
| sgl@sicat.com | |
| Phone | +49228286206600 |
| sgl@sicat.com | |
| Phone | +49228286206600 |
| sgl@sicat.com | |
| Phone | +49228286206600 |
| sgl@sicat.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D776103010 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-12 |
| Device Publish Date | 2022-08-04 |
| 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 | 2022-08-12SICAT SURGICAL GUIDE |
| D776103010 - SICAT SURGICAL GUIDE | 2022-08-12 SICAT SURGICAL GUIDE |
| D776AIRV20400 - SICAT Air | 2022-01-20 |