| Primary Device ID | 06438408005862 |
| NIH Device Record Key | 99898e40-b327-47e8-8e65-77aa6423bf53 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 2.5 mm Inion OTPS™ |
| Version Model Number | 1 |
| Catalog Number | FRF-1023 |
| Company DUNS | 367994657 |
| Company Name | Inion Oy |
| 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 | 06438408005862 [Primary] |
| HRS | Plate, fixation, bone |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-09 |
| Device Publish Date | 2023-09-29 |
| M224FRF10419 | 4 hole plate, extended long |
| M224FRF10369 | 10 hole plate |
| M224FRF10279 | 8 hole plate |
| M224FRF10269 | 6 hole plate, extended |
| M224FRF10259 | 6 hole plate |
| M224FRF10249 | 4 hole plate, extended |
| M224FRF10239 | 4 hole plate |
| 06438408005961 | 4 hole plate, extended long |
| 06438408005916 | 10 hole plate |
| 06438408005909 | 8 hole plate |
| 06438408005893 | 6 hole plate, extended |
| 06438408005886 | 6 hole plate |
| 06438408005879 | 4 hole plate, extended |
| 06438408005862 | 4 hole plate |