| Primary Device ID | D7702469323 |
| NIH Device Record Key | f6b82398-56e0-4e8c-bf4c-2234c9e4830b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IMPLANT ZIRTI |
| Version Model Number | SH-ZT-PS500SL-100 |
| Catalog Number | SH-ZT-PS500SL-100 |
| 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 | D7702469323 [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 | 2023-05-08 |
| Device Publish Date | 2023-04-28 |
| 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 |