| Primary Device ID | 05902768365306 |
| NIH Device Record Key | 0d329b06-bb24-406c-8fb6-aab8d3b9002b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3Shape Implant Studio |
| Version Model Number | 2016-1 |
| Company DUNS | 305500094 |
| Company Name | 3shape Medical A/S |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +4570272620 |
| support@3shape.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05902768365306 [Primary] |
| LLZ | System, Image Processing, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-25 |
| 05902729753265 - Implant Studio | 2020-11-02 Dental treatment application software |
| 05902729750448 - Implant Studio | 2018-04-02 Dental treatment application software |
| 05902729750455 - CT Preparation | 2018-04-02 Dental treatment application software |
| 05902768365306 - 3Shape Implant Studio | 2018-03-29IMPLANT STUDIO IPGS (Implant Planning and Surgical Guide) is intended to be used as pre-operative planning soft-ware to plan the placement of one or m |
| 05902768365306 - 3Shape Implant Studio | 2018-03-29 IMPLANT STUDIO IPGS (Implant Planning and Surgical Guide) is intended to be used as pre-operative planning soft-ware to plan the |