| Primary Device ID | D7700855623 | 
| NIH Device Record Key | 8474a6b6-7387-4dbc-873c-139389a99e0b | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | PREMIUM IMPLANT ZIRTI TG | 
| Version Model Number | A-ZT-380TG-115 | 
| Catalog Number | A-ZT-380TG-115 | 
| 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | D7700855623 [Primary] | 
| DZE | Implant, Endosseous, Root-Form | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 3 | 
| Public Version Date | 2018-07-06 | 
| Device Publish Date | 2015-09-21 | 
| D7700868473 | PREMIUM IMPLANT ZIRTI TG D.5.00 H.15 MM | 
| D7700868463 | PREMIUM IMPLANT ZIRTI TG D.5.00 H.13 MM | 
| D7700868453 | PREMIUM IMPLANT ZIRTI TG D.5.00 H.10 MM | 
| D7700868443 | PREMIUM IMPLANT ZIRTI TG D.5.00 H.7 MM | 
| D7700868433 | PREMIUM IMPLANT ZIRTI TG D.5.00 H.6 MM | 
| D7700868423 | PREMIUM IMPLANT ZIRTI TG D.4.25 H.13 MM | 
| D7700868413 | PREMIUM IMPLANT ZIRTI TG D.4.25 H.11.5 MM | 
| D7700868403 | PREMIUM IMPLANT ZIRTI TG D.4.25 H.10 MM | 
| D7700868393 | PREMIUM IMPLANT ZIRTI TG D.4.25 H.8.5 MM | 
| D7700868383 | PREMIUM IMPLANT ZIRTI TG D.4.25 H.7 MM | 
| D7700868373 | PREMIUM IMPLANT ZIRTI TG D.4.25 H.6 MM | 
| D7700868363 | PREMIUM IMPLANT ZIRTI TG D.3.80 H.7 MM | 
| D7700868353 | PREMIUM IMPLANT ZIRTI TG D.3.80 H.6 MM | 
| D7700868343 | PREMIUM IMPLANT ZIRTI TG D.3.30 H.11.5 MM | 
| D7700855673 | PREMIUM IMPLANT ZIRTI TG D.5.00 H.11.5 MM | 
| D7700855663 | PREMIUM IMPLANT ZIRTI TG D.5.00 H.8.5 MM | 
| D7700855653 | PREMIUM IMPLANT ZIRTI TG D.4.25 H.15 MM | 
| D7700855643 | PREMIUM IMPLANT ZIRTI TG D.3.80 H.15 MM | 
| D7700855633 | PREMIUM IMPLANT ZIRTI TG D.3.80 H.13 MM | 
| D7700855623 | PREMIUM IMPLANT ZIRTI TG D.3.80 H.11.5 MM | 
| D7700855613 | PREMIUM IMPLANT ZIRTI TG D.3.80 H.10 MM | 
| D7700855603 | PREMIUM IMPLANT ZIRTI TG D.3.80 H.8.5 MM | 
| D7700855593 | PREMIUM IMPLANT ZIRTI TG D.3.30 H.15 MM | 
| D7700855583 | PREMIUM IMPLANT ZIRTI TG D.3.30 H.13 MM | 
| D7700855573 | PREMIUM IMPLANT ZIRTI TG D.3.30 H.10 MM |