| Primary Device ID | D7701324933 |
| NIH Device Record Key | 3c2f015e-456e-455b-abdc-fe921be9570a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INTRAORAL SCANBODY |
| Version Model Number | AS-INT-CAMTRA425 |
| Catalog Number | AS-INT-CAMTRA425 |
| 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 | D7701324933 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D7701324933]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-04-12 |
| Device Publish Date | 2018-03-12 |
| D7701324943 | INTRAORAL SCANBODY TRANSFER 5.00 |
| D7701324933 | INTRAORAL SCANBODY TRANSFER 4.25 |
| D7701457843 | INTRAORAL SCANBODY D.3.30 MM |
| D7701457793 | INTRAORAL SCANBODY D.3.80 MM |
| D7701457783 | INTRAORAL SCANBODY D.3.30 MM |
| D7701457883 | INTRAORAL SCANBODY XA |
| D7701457873 | INTRAORAL SCANBODY PLAIN |
| D7701457863 | INTRAORAL SCANBODY PAD |
| D7701814873 | INTRAORAL SCANBODY FOR RED. PAD |
| D7701457803 | INTRAORAL SCANBODY D.3.30 MM |