| Primary Device ID | D7700855663 |
| NIH Device Record Key | 5ee82769-7ac0-40fc-a821-8363cc9b4da1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PREMIUM IMPLANT ZIRTI TG |
| Version Model Number | A-ZT-500TG-085 |
| Catalog Number | A-ZT-500TG-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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D7700855663 [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 |