| Primary Device ID | D7701304913 | 
| NIH Device Record Key | 9e48ec6d-77b0-4837-ac63-775e1dfcdd31 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | KOHNO ONE IMPLANT ZIRTI | 
| Version Model Number | KS-ZT-425-150 | 
| Catalog Number | KS-ZT-425-150 | 
| Company DUNS | 433815198 | 
| Company Name | SWEDEN & MARTINA SPA | 
| 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 | true | 
| Lot Batch | true | 
| Serial Number | true | 
| Manufacturing Date | false | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | 844.862.7846 | 
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 | 
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 | 
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 | 
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 | 
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 | 
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 | 
| info.us@sweden-martina.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | D7701304913 [Primary] | 
| DZE | Implant, Endosseous, Root-Form | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-07-07 | 
| Device Publish Date | 2022-06-29 | 
| D7701304953 | KOHNO ONE IMPLANT ZIRTI ZT D.5.00 H.13 MM | 
| D7701304943 | KOHNO ONE IMPLANT ZIRTI ZT D.5.00 H.11.5 MM | 
| D7701304933 | KOHNO ONE IMPLANT ZIRTI ZT D.5.00 H.10 MM | 
| D7701304923 | KOHNO ONE IMPLANT ZIRTI ZT D.4.25 H.18 MM | 
| D7701304913 | KOHNO ONE IMPLANT ZIRTI ZT D.4.25 H.15 MM | 
| D7701304903 | KOHNO ONE IMPLANT ZIRTI ZT D.4.25 H.13 MM | 
| D7701304893 | KOHNO ONE IMPLANT ZIRTI ZT D.4.25 H.11.5 MM | 
| D7701304883 | KOHNO ONE IMPLANT ZIRTI ZT D.4.25 H.10 MM |