| Primary Device ID | 06438408004728 |
| NIH Device Record Key | 60d8cfc8-b813-4740-a691-e9c306a4f81b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Inion OTPS Pin Instruments |
| Version Model Number | 1 |
| Catalog Number | INS-9242 |
| Company DUNS | 367994657 |
| Company Name | Inion Oy |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06438408004728 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06438408004728]
Moist Heat or Steam Sterilization
[06438408004728]
Moist Heat or Steam Sterilization
[06438408004728]
Moist Heat or Steam Sterilization
[06438408004728]
Moist Heat or Steam Sterilization
[06438408004728]
Moist Heat or Steam Sterilization
[06438408004728]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-06-10 |
| Device Publish Date | 2020-06-16 |
| M224INS92469 | Percutaneous drill 2.0 mm |
| 06438408004735 | Percutaneous piston 2.0mm |
| M224INS92319 | Pin applicator 2.0 mm |
| M224INS92309 | Pin applicator 1.5 mm |
| M224ACC98209 | Sterilization tray |
| 06438408004728 | Percutaneous tip 2.0 mm |
| M224INS92349 | Arthroscopic tip 2.0 mm |