| Primary Device ID | D7701106273 |
| NIH Device Record Key | 8c59acf9-f0fa-40d0-939d-7c9bfeaf5503 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PREMIUM STRAIGHT IMPLANT ZIRTI |
| Version Model Number | A-ZT-330-085 |
| Catalog Number | A-ZT-330-085 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D7701106273 [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 | 2022-01-20 |
| Device Publish Date | 2022-01-12 |
| D7700843493 | PREMIUM STRAIGHT IMPLANT ZIRTI D.5.00 H.15 MM |
| D7700843453 | PREMIUM STRAIGHT IMPLANT ZIRTI D.4.25 H.18 MM |
| D7700843443 | PREMIUM STRAIGHT IMPLANT ZIRTI D.4.25 H.15 MM |
| D7700843423 | PREMIUM STRAIGHT IMPLANT ZIRTI D.3.80 H.18 MM |
| D7700626363 | PREMIUM STRAIGHT IMPLANT ZIRTI D.5.00 H.13 MM |
| D7700626353 | PREMIUM STRAIGHT IMPLANT ZIRTI D.5.00 H.11.5 MM |
| D7700626343 | PREMIUM STRAIGHT IMPLANT ZIRTI D.5.00 H.10 MM |
| D7700626333 | PREMIUM STRAIGHT IMPLANT ZIRTI D.5.00 H.8.5 MM |
| D7700626323 | PREMIUM STRAIGHT IMPLANT ZIRTI D.5.00 H.7 MM |
| D7700626313 | PREMIUM STRAIGHT IMPLANT ZIRTI D.4.25 H.13 MM |
| D7700626303 | PREMIUM STRAIGHT IMPLANT ZIRTI D.4.25 H.11.5 MM |
| D7700626293 | PREMIUM STRAIGHT IMPLANT ZIRTI D.4.25 H.10 MM |
| D7700626283 | PREMIUM STRAIGHT IMPLANT ZIRTI D.4.25 H.8.5 MM |
| D7700626273 | PREMIUM STRAIGHT IMPLANT ZIRTI D.4.25 H.7 MM |
| D7700626263 | PREMIUM STRAIGHT IMPLANT ZIRTI D.3.80 H.15 MM |
| D7700626253 | PREMIUM STRAIGHT IMPLANT ZIRTI D.3.80 H.13 MM |
| D7700626233 | PREMIUM STRAIGHT IMPLANT ZIRTI D.3.80 H.11.5 MM |
| D7700626223 | PREMIUM STRAIGHT IMPLANT ZIRTI D.3.30 H.10 MM |
| D7700626213 | PREMIUM STRAIGHT IMPLANT ZIRTI D.3.80 H.8.50 MM |
| D7700626203 | PREMIUM STRAIGHT IMPLANT ZIRTI D.3.30 H.15 MM |
| D7700626193 | PREMIUM STRAIGHT IMPLANT ZIRTI D.3.30 H.13 MM |
| D7700626183 | PREMIUM STRAIGHT IMPLANT ZIRTI D.3.30 H.11.5 MM |
| D7701106273 | PREMIUM STRAIGHT IMPLANT ZIRTI D.3.30 H.8.5 MM |