| Primary Device ID | 05065012584257 |
| NIH Device Record Key | d8587b91-14c3-4fb6-82b9-fa5349169e34 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Reusable 5mm Pro Shim |
| Version Model Number | RS500 |
| Company DUNS | 226230358 |
| Company Name | EVENTUM ORTHOPAEDICS LTD |
| 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 | false |
| 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 |
| Phone | +442045428754 |
| regulatory@eventumortho.com | |
| Phone | +442045428754 |
| regulatory@eventumortho.com | |
| Phone | +442045428754 |
| regulatory@eventumortho.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05065012584257 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[05065012584257]
Moist Heat or Steam Sterilization
[05065012584257]
Moist Heat or Steam Sterilization
[05065012584257]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-13 |
| Device Publish Date | 2026-02-05 |
| 05065012584257 - Reusable 5mm Pro Shim | 2026-02-135mm Spacer for Patella Assessment. |
| 05065012584257 - Reusable 5mm Pro Shim | 2026-02-13 5mm Spacer for Patella Assessment. |
| 05065012584264 - Reusable 5mm 2.5 degree Pro shim | 2026-02-13 5mm, 2.5 Degree, Spacer for Patella Assessment. |
| 05065012584271 - Reusable 6mm Pro shim | 2026-02-13 6mm Spacer for Patella Assessment. |
| 05065012584288 - Reusable 6mm 2.5 degree Pro shim | 2026-02-13 6mm, 2.5 Degree, Spacer for Patella Assessment. |
| 05065012584295 - Reusable 7mm Pro shim | 2026-02-13 7mm Spacer for Patella Assessment. |
| 05065012584301 - Reusable 7mm 2.5 degree Pro shim | 2026-02-13 7mm, 2.5 Degree, Spacer for Patella Assessment. |
| 05065012584318 - Reusable 8mm Pro shim | 2026-02-13 8mm Spacer for Patella Assessment. |
| 05065012584325 - Reusable 8mm 2.5 degree Pro shim | 2026-02-13 8mm, 2.5 Degree, Spacer for Patella Assessment. |