| Primary Device ID | D7702466463 | 
| NIH Device Record Key | 75c22def-fa7b-4d84-aa87-3a19e95a95f7 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | IMPLANT ZIRTI | 
| Version Model Number | A-ZT-P330-085 | 
| Catalog Number | A-ZT-P330-085 | 
| 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 | |
| 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 | |
| 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 | D7702466463 [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 | 2023-05-05 | 
| Device Publish Date | 2023-04-27 | 
| D7702466943 | IMPLANT ZIRTI D5.00 H15 MM | 
| D7702466933 | IMPLANT ZIRTI D5.00 H13 MM | 
| D7702466923 | IMPLANT ZIRTI D5.00 H11.5 MM | 
| D7702466913 | IMPLANT ZIRTI D5.00 H10 MM | 
| D7702466903 | IMPLANT ZIRTI D5.00 H8.5 MM | 
| D7702466883 | IMPLANT ZIRTI D5.00 H7 MM | 
| D7702466873 | IMPLANT ZIRTI D4.25 H26 MM | 
| D7702466863 | IMPLANT ZIRTI D4.25 H24 MM | 
| D7702466853 | IMPLANT ZIRTI D4.25 H22 MM | 
| D7702466843 | IMPLANT ZIRTI D4.25 H20 MM | 
| D7702466833 | IMPLANT ZIRTI D4.25 H18 MM | 
| D7702466823 | IMPLANT ZIRTI D4.25 H15 MM | 
| D7702466813 | IMPLANT ZIRTI D4.25 H13 MM | 
| D7702466793 | IMPLANT ZIRTI D4.25 H11.5 MM | 
| D7702466773 | IMPLANT ZIRTI D4.25 H10 MM | 
| D7702466753 | IMPLANT ZIRTI D4.25 H8.5 MM | 
| D7702466733 | IMPLANT ZIRTI D4.25 H7 MM | 
| D7702466713 | IMPLANT ZIRTI D3.80 H26 MM | 
| D7702466673 | IMPLANT ZIRTID3.80 H24 MM | 
| D7702466653 | IMPLANT ZIRTI D3.80 H22 MM | 
| D7702466643 | IMPLANT ZIRTI D3.80 H20 MM | 
| D7702466623 | IMPLANT ZIRTI D3.80 H18 MM | 
| D7702466603 | IMPLANT ZIRTI D3.80 H15 MM | 
| D7702466583 | IMPLANT ZIRTI D3.80 H13 MM | 
| D7702466563 | IMPLANT ZIRTI D3.80 H11.5 MM | 
| D7702466533 | IMPLANT ZIRTI D3.80 H10 MM | 
| D7702466523 | IMPLANT ZIRTI D3.80 H8.5 MM | 
| D7702466513 | IMPLANT ZIRTI D3.80 H7 MM | 
| D7702466503 | IMPLANT ZIRTI D3.30 H15 MM | 
| D7702466493 | IMPLANT ZIRTI D3.30 H13 MM | 
| D7702466483 | IMPLANT ZIRTI D3.30 H11.5 MM | 
| D7702466473 | IMPLANT ZIRTI D3.30 H10 MM | 
| D7702466463 | IMPLANT ZIRTI D3.30 H8.5 MM | 
| D7702469353 | IMPLANT ZIRTI D.5.00 H.15 MM | 
| D7702469343 | IMPLANT ZIRTI D.5.00 H.13 MM | 
| D7702469333 | IMPLANT ZIRTI D.5.00 H.11.5 MM | 
| D7702469323 | IMPLANT ZIRTI D.5.00 H.10 MM | 
| D7702469313 | IMPLANT ZIRTI D.5.00 H.8.5 MM | 
| D7702469303 | IMPLANT ZIRTI D.4.25 H.15 MM | 
| D7702469293 | IMPLANT ZIRTI D.4.25 H.13 MM | 
| D7702469283 | IMPLANT ZIRTI D.4.25 H.11.5 MM | 
| D7702469273 | IMPLANT ZIRTI D.4.25 H.10 MM | 
| D7702469263 | IMPLANT ZIRTI D.4.25 H.8.5 MM | 
| D7702469253 | IMPLANT ZIRTI D.3.80 H.15 MM | 
| D7702469243 | IMPLANT ZIRTI D.3.80 H.13 MM | 
| D7702469233 | IMPLANT ZIRTI D.3.80 H.11.5 M | 
| D7702469223 | IMPLANT ZIRTI D.3.80 H.10 MM | 
| D7702469193 | IMPLANT ZIRTI D.3.80 H.8.5 MM | 
| D7702469183 | IMPLANT ZIRTI D.5.00 H.15 MM | 
| D7702469173 | IMPLANT ZIRTI D.5.00 H.13 MM |