| Primary Device ID | 06438408008115 |
| NIH Device Record Key | f2742bbf-1e1a-4e2f-a438-675eee54ee8c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Inion CompressOn™ Instrument |
| Version Model Number | 1 |
| Catalog Number | IFS-9026 |
| 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 | 06438408008115 [Primary] |
| FZX | Guide, surgical, instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06438408008115]
Moist Heat or Steam Sterilization
[06438408008115]
Moist Heat or Steam Sterilization
[06438408008115]
Moist Heat or Steam Sterilization
[06438408008115]
Moist Heat or Steam Sterilization
[06438408008115]
Moist Heat or Steam Sterilization
[06438408008115]
Moist Heat or Steam Sterilization
[06438408008115]
Moist Heat or Steam Sterilization
[06438408008115]
Moist Heat or Steam Sterilization
[06438408008115]
Moist Heat or Steam Sterilization
[06438408008115]
Moist Heat or Steam Sterilization
[06438408008115]
Moist Heat or Steam Sterilization
[06438408008115]
Moist Heat or Steam Sterilization
[06438408008115]
Moist Heat or Steam Sterilization
[06438408008115]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-22 |
| Device Publish Date | 2021-03-12 |
| 06438408009723 | Drill tap Ø 4.5 Cannulated, short |
| 06438408009716 | Drill tap Ø, 4.0 Cannulated, short |
| 06438408009709 | Drill Ø 3.2 Cannulated, short |
| 06438408008948 | K-wire Ø 2.0x230 mm |
| 06438408008931 | K-wire Ø 1.6x150 mm |
| 06438408008924 | K-wire Ø 1.25x150 mm |
| 06438408008917 | K-wire Ø 0.8x150 mm |
| 06438408008900 | Depth gauge for 150 mm K-wire |
| 06438408008894 | Depth gauge for 230 mm K-wire |
| 06438408008115 | Drill sleeve Ø4.2/6.0 mm, for Ø 6.0 mm screws |
| 06438408008108 | Drill sleeve Ø3.7/5.0 mm, for Ø 5.0 mm screws |
| 06438408008092 | Drill tap Ø 6.0 mm, cannulated |
| 06438408008085 | Drill tap Ø 5.0 mm, cannulated |
| 06438408008061 | Drill tap Ø 2.7 mm, cannulated |
| 06438408008054 | Drill Ø 4.2 mm, cannulated |
| 06438408008047 | Drill Ø 3.7 mm, cannulated |
| 06438408008023 | Drill Ø 2.0 mm, cannulated |
| 06438408008016 | Screwdriver shaft, T25 |
| 06438408008009 | Screwdriver shaft, T15 |
| 06438408007996 | Screwdriver shaft, T8 |
| 06438408007989 | Screwdriver shaft, T7 |
| 06438408012013 | CompressOn Headless Screw Tray |