| Primary Device ID | D7701556073 | 
| NIH Device Record Key | 81e57ee5-619a-48e5-8989-8400a3b3351c | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | PRAMA RF IMPLANT ZIRTI | 
| Version Model Number | LS-ZT-425SL-180 | 
| Catalog Number | LS-ZT-425SL-180 | 
| 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | D7701556073 [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 | 2025-08-12 | 
| Device Publish Date | 2025-08-04 | 
| D7701556073 | PRAMA RF IMPLANT ZIRTI WIDE THREAD D. 4.25 H. 18 MM | 
| D7701556003 | PRAMA RF IMPLANT ZIRTI WIDE THREAD D. 3.80 H. 18 MM |