| Primary Device ID | 00880019600961 |
| NIH Device Record Key | 6a64e069-ff52-46f5-9499-901d7dd9db88 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lilivis SCAN OPTOMO |
| Version Model Number | LSO-100 |
| Catalog Number | Y4XXCL-24-00001 |
| Company DUNS | 688154202 |
| Company Name | Huvitz Co., Ltd. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +82313600082 |
| cs@ossvis.com | |
| Phone | +82313600082 |
| cs@ossvis.com | |
| Phone | +82313600082 |
| cs@ossvis.com | |
| Phone | +82313600082 |
| cs@ossvis.com | |
| Phone | +82313600082 |
| cs@ossvis.com | |
| Phone | +82313600082 |
| cs@ossvis.com | |
| Phone | +82313600082 |
| cs@ossvis.com | |
| Phone | +82313600082 |
| cs@ossvis.com | |
| Phone | +82313600082 |
| cs@ossvis.com | |
| Phone | +82313600082 |
| cs@ossvis.com | |
| Phone | +82313600082 |
| cs@ossvis.com | |
| Phone | +82313600082 |
| cs@ossvis.com | |
| Phone | +82313600082 |
| cs@ossvis.com | |
| Phone | +82313600082 |
| cs@ossvis.com | |
| Phone | +82313600082 |
| cs@ossvis.com | |
| Phone | +82313600082 |
| cs@ossvis.com | |
| Phone | +82313600082 |
| cs@ossvis.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00880019600961 [Primary] |
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00880019600961]
Moist Heat or Steam Sterilization
[00880019600961]
Moist Heat or Steam Sterilization
[00880019600961]
Moist Heat or Steam Sterilization
[00880019600961]
Moist Heat or Steam Sterilization
[00880019600961]
Moist Heat or Steam Sterilization
[00880019600961]
Moist Heat or Steam Sterilization
[00880019600961]
Moist Heat or Steam Sterilization
[00880019600961]
Moist Heat or Steam Sterilization
[00880019600961]
Moist Heat or Steam Sterilization
[00880019600961]
Moist Heat or Steam Sterilization
[00880019600961]
Moist Heat or Steam Sterilization
[00880019600961]
Moist Heat or Steam Sterilization
[00880019600961]
Moist Heat or Steam Sterilization
[00880019600961]
Moist Heat or Steam Sterilization
[00880019600961]
Moist Heat or Steam Sterilization
[00880019600961]
Moist Heat or Steam Sterilization
[00880019600961]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-04 |
| Device Publish Date | 2024-11-26 |
| 00880019600961 - Lilivis SCAN OPTOMO | 2024-12-04Huvitz Dental Intraoral Scanner OCT (LSO-100) is a dental 3D scanner intended to be used to digitally record topographical characteristics of teeth and surrounding tissues. LSO-100 produces 3D scans for use in computer-assisted design and manufacturing of dental restorations. |
| 00880019600961 - Lilivis SCAN OPTOMO | 2024-12-04 Huvitz Dental Intraoral Scanner OCT (LSO-100) is a dental 3D scanner intended to be used to digitally record topographical chara |
| 08800019600978 - Instrument Table CIT-4100 | 2024-07-02 Instrument Table CIT-4100 |
| 08800019600985 - Instrument Table CIT-4200 | 2024-07-02 Instrument Table CIT-4200 |
| 08800019600893 - Lilivis Scan LS-100 | 2024-06-04 Lilivis Scan LS-100 (Intraoral Scanner) |
| 08800019600909 - Lilivis CAD L-CAD | 2024-06-04 Lilivis CAD L-CAD (Chairside CAD Software) |
| 08800019600787 - Optical Biometer HBM-1 | 2023-10-26 The Optical Biometer HBM-1 is a medical device that optically measures eye components such as: *Axial length *Corneal curvature |
| 08800019600916 - Digital Refractor HDR-7100P | 2023-09-01 The HUVITZ Digital Refractor HDR-7100P system is a computerized auto refractor used for subjective refraction by regarding the p |
| 08800019600923 - Auto Ref/Keratometer HRK-8100A | 2023-09-01 Auto Ref/Keratometer HRK-8100A is intended to provide the information of Spherical, Cylindrical and Axis while measuring the ref |