| Primary Device ID | 08806390800150 |
| NIH Device Record Key | dcf4dda8-648a-4b49-8905-917d6b843b0d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ARIX Ankle System Bone Plate |
| Version Model Number | 35-DLST-005 |
| Company DUNS | 688811603 |
| Company Name | Jeil Medical Corporation |
| 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 | 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 | 08806390800150 [Primary] |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08806390800150]
Moist Heat or Steam Sterilization
[08806390800150]
Moist Heat or Steam Sterilization
[08806390800150]
Moist Heat or Steam Sterilization
[08806390800150]
Moist Heat or Steam Sterilization
[08806390800150]
Moist Heat or Steam Sterilization
[08806390800150]
Moist Heat or Steam Sterilization
[08806390800150]
Moist Heat or Steam Sterilization
[08806390800150]
Moist Heat or Steam Sterilization
[08806390800150]
Moist Heat or Steam Sterilization
[08806390800150]
Moist Heat or Steam Sterilization
[08806390800150]
Moist Heat or Steam Sterilization
[08806390800150]
Moist Heat or Steam Sterilization
[08806390800150]
Moist Heat or Steam Sterilization
[08806390800150]
Moist Heat or Steam Sterilization
[08806390800150]
Moist Heat or Steam Sterilization
[08806390800150]
Moist Heat or Steam Sterilization
[08806390800150]
Moist Heat or Steam Sterilization
[08806390800150]
Moist Heat or Steam Sterilization
[08806390800150]
Moist Heat or Steam Sterilization
[08806390800150]
Moist Heat or Steam Sterilization
[08806390800150]
Moist Heat or Steam Sterilization
[08806390800150]
Moist Heat or Steam Sterilization
[08806390800150]
Moist Heat or Steam Sterilization
[08806390800150]
Moist Heat or Steam Sterilization
[08806390800150]
Moist Heat or Steam Sterilization
[08806390800150]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2024-06-07 |
| Device Publish Date | 2015-11-23 |