| Primary Device ID | 09010522000847 |
| NIH Device Record Key | bb2424c6-fee3-4a7d-821d-305a44058ced |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Osstell IDx Instrument |
| Version Model Number | Osstell Osstell IDx Instrument |
| Catalog Number | 101000 |
| Company DUNS | 633171269 |
| Company Name | Osstell AB |
| 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 | false |
| Serial Number | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09010522000847 [Package] Contains: 09010522000892 Package: Box [1 Units] In Commercial Distribution |
| GS1 | 09010522000854 [Package] Contains: 09010522000892 Package: Box DEMO [1 Units] In Commercial Distribution |
| GS1 | 09010522000892 [Primary] |
| EKX | Handpiece, Direct Drive, Ac-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-06-04 |
| Device Publish Date | 2022-11-01 |
| 09010522000731 - Osstell ISQ Probe | 2024-09-19 ISQ Measurement Instrument Accessory |
| 09010522002315 - Osstell SmartPeg Type 110 | 2024-09-19 ISQ Measurement Peg |
| 09010522002322 - Osstell SmartPeg Type 111 | 2024-09-19 ISQ Measurement Peg |
| 09010522000847 - Osstell IDx Instrument | 2024-06-04ISQ Measurement Instrument |
| 09010522000847 - Osstell IDx Instrument | 2024-06-04 ISQ Measurement Instrument |
| 09010522001134 - DIO IDx Instrument | 2024-06-04 ISQ Measurement Instrument |
| 09010522002476 - SmartPeg Type 117 | 2024-05-23 ISQ Measurement Peg |
| 09010522002070 - SmartPeg Type 98 - Neoss | 2024-05-22 ISQ Measurement Peg |
| 09010522002469 - Neoss SmartPeg Mount | 2023-12-14 SmartPeg Mount |