| Primary Device ID | 04026575341153 |
| NIH Device Record Key | 6f6b9712-4227-4a2c-bccd-3b08998c0161 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Endo-Model Knee Fusion Nail SK Instruments |
| Version Model Number | 15-8450/03 |
| Company DUNS | 315675488 |
| Company Name | WALDEMAR LINK GmbH & Co. KG |
| 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 | 04026575341153 [Primary] |
| HXG | Tamp |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04026575341153]
Moist Heat or Steam Sterilization
[04026575341153]
Moist Heat or Steam Sterilization
[04026575341153]
Moist Heat or Steam Sterilization
[04026575341153]
Moist Heat or Steam Sterilization
[04026575341153]
Moist Heat or Steam Sterilization
[04026575341153]
Moist Heat or Steam Sterilization
[04026575341153]
Moist Heat or Steam Sterilization
[04026575341153]
Moist Heat or Steam Sterilization
[04026575341153]
Moist Heat or Steam Sterilization
[04026575341153]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-10 |
| Device Publish Date | 2026-02-02 |
| 04026575426096 | Instrument Tray, Stainless Steel, empty, L= 478 mm H= 76 mm, W= 253 mm |
| 04026575341153 | Inserter-Extractor, threaded, Stainless Steel, for femoral component of Knee Fusion Nails |