| Primary Device ID | 09010522002131 |
| NIH Device Record Key | 485008ba-fec5-4506-a60a-7b790ef269e4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Osstell SmartPeg Type 101 |
| Version Model Number | Osstell SmartPeg Type 101 |
| Catalog Number | 100766 |
| 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 | true |
| 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 | 09010522002124 [Package] Package: box [5 Units] In Commercial Distribution |
| GS1 | 09010522002131 [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 | 2023-11-09 |
| Device Publish Date | 2023-11-01 |
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