| Primary Device ID | 04026575242702 |
| NIH Device Record Key | 810415f0-b50a-4dd8-afbe-4f4f9d56653c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Megasystem-C Tumor- and Revision System - Instruments |
| Version Model Number | 16-3241/02 |
| 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 | 04026575242702 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04026575242702]
Moist Heat or Steam Sterilization
[04026575242702]
Moist Heat or Steam Sterilization
[04026575242702]
Moist Heat or Steam Sterilization
[04026575242702]
Moist Heat or Steam Sterilization
[04026575242702]
Moist Heat or Steam Sterilization
[04026575242702]
Moist Heat or Steam Sterilization
[04026575242702]
Moist Heat or Steam Sterilization
[04026575242702]
Moist Heat or Steam Sterilization
[04026575242702]
Moist Heat or Steam Sterilization
[04026575242702]
Moist Heat or Steam Sterilization
[04026575242702]
Moist Heat or Steam Sterilization
[04026575242702]
Moist Heat or Steam Sterilization
[04026575242702]
Moist Heat or Steam Sterilization
[04026575242702]
Moist Heat or Steam Sterilization
[04026575242702]
Moist Heat or Steam Sterilization
[04026575242702]
Moist Heat or Steam Sterilization
[04026575242702]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-01-10 |
| Device Publish Date | 2022-12-27 |
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| 04026575242726 | Orthopaedic implant aiming/guiding block, reusable - Megasystem-C Tumor- and Revision System |
| 04026575242719 | Orthopaedic implant aiming/guiding block, reusable - Megasystem-C Tumor- and Revision System |
| 04026575242702 | Orthopaedic implant aiming/guiding block, reusable - Megasystem-C Tumor- and Revision System |
| 04026575155538 | Orthopaedic implant inserter/extractor, reusable - General Instrument |