| Primary Device ID | D7701278503 |
| NIH Device Record Key | c81fa119-0df7-4b6f-a3a8-d9619eb7031b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ANALOGUE FOR ABUTMENT |
| Version Model Number | SH-INT-CAMANA-425 |
| Catalog Number | SH-INT-CAMANA-425 |
| Company DUNS | 433815198 |
| Company Name | SWEDEN & MARTINA SPA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | D7701278503 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D7701278503]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-07-26 |
| D7701278373 | ANALOGUE FOR ABUTMENT INTRAORAL 500 |
| D7701278363 | ANALOGUE FOR ABUTMENT INTRAORAL 425 |
| D7701278353 | ANALOGUE FOR ABUTMENT INTRAORAL 380 |
| D7701278343 | ANALOGUE FOR ABUTMENT INTRAORAL 330 |
| D7700836493 | ANALOGUE FOR ABUTMENT PREMIUM D.3.30 MM |
| D7700640383 | ANALOGUE FOR ABUTMENT PRE-KOH D.4.25 MM |
| D7700640373 | ANALOGUE FOR ABUTMENT PRE-KOH D.3.80 MM |
| D7701278563 | ANALOGUE FOR ABUTMENT INTRAORAL 600 |
| D7701278513 | ANALOGUE FOR ABUTMENT INTRAORAL 500 |
| D7701278503 | ANALOGUE FOR ABUTMENT INTRAORAL 425 |