| Primary Device ID | D77010645637 |
| NIH Device Record Key | 40edfb2e-17a4-42c3-a932-0a6d4828f08d |
| Commercial Distribution Discontinuation | 2015-10-13 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | OUTLINK2 IMPLANT ZIRTI |
| Version Model Number | E2-ZT-330-100 |
| Catalog Number | E2-ZT-330-100 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D77010645637 [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 | 2015-10-13 |
| D7702694543 - SURGICAL KIT | 2025-05-07 SURGICAL KIT PRAMA GS 5.0 |
| D7702693313 - SURGICAL KIT | 2025-04-28 SURGICAL KIT GS 5.0 |
| D7702693393 - BONE PROFILER SLEEVE | 2025-04-28 BONE PROFILER SLEEVE 5.0 |
| D7702693553 - PILOT DRILL | 2025-04-28 PILOT DRILL SLEEVE 5.0 D.2.00 L.4.00 MM |
| D7702693643 - COUNTERSINK DRILL | 2025-04-28 COUNTERSINK DRILL SLEEVE 5.0 D.5.00 MM |
| D7702693653 - COUNTERSINK DRILL | 2025-04-28 COUNTERSINK DRILL SLEEVE 5.0 D.4.25 MM |
| D7702693663 - COUNTERSINK DRILL | 2025-04-28 COUNTERSINK DRILL SLEEVE 5.0 D.3.80 MM |
| D7702693673 - COUNTERSINK DRILL | 2025-04-28 COUNTERSINK DRILL SLEEVE 5.0 D.3.30 MM |