| Primary Device ID | 09010522000076 |
| NIH Device Record Key | d793bc8b-2ecc-4cc6-ad05-ed1a049c5da1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Osstell SmartPeg Type 06 |
| Version Model Number | Osstell SmartPeg Type 06 |
| Catalog Number | 100378 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09010522000076 [Package] Contains: 09010522001219 Package: Box [5 Units] In Commercial Distribution |
| GS1 | 09010522001219 [Primary] |
| EKX | Handpiece, Direct Drive, Ac-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-12 |
| Device Publish Date | 2022-09-02 |
| 09010522002551 - Osstell SmartPeg Type 112 | 2025-04-04 ISQ Measurement Peg |
| 09010522002568 - Osstell SmartPeg Type 113 | 2025-04-04 ISQ Measurement Peg |
| 09010522002582 - Osstell SmartPeg Type 114 | 2025-04-04 ISQ Measurement Peg |
| 09010522002605 - Osstell SmartPeg Type 115 | 2025-04-04 ISQ Measurement Peg |
| 09010522002636 - Osstell Classic Instrument | 2025-03-31 ISQ Measurement Instrument |
| 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 |