| Primary Device ID | 00855106005226 |
| NIH Device Record Key | 0641d1f1-fb07-4f5c-8ac6-017415e2b6b7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LINX Esophagus Sizing Tool |
| Version Model Number | LSSUS |
| Company DUNS | 137949538 |
| Company Name | Torax Medical, Inc. |
| Device Count | 5 |
| 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 | false |
| Expiration Date | true |
| 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 | 00855106005219 [Unit of Use] |
| GS1 | 00855106005226 [Primary] |
| LEI | Implant, Anti-Gastroesophageal Reflux |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-12-31 |
| Device Publish Date | 2014-09-10 |
| 00855106005219 - LINX | 2021-03-01 LINX Esophagus Sizing Tools |
| 30855106005432 - ETHICON Linx Esophagus Sizing Tool | 2020-12-31 ETHICON Linx Esophagus Sizing Tool |
| 00855106005226 - LINX Esophagus Sizing Tool | 2018-12-31 |
| 00855106005226 - LINX Esophagus Sizing Tool | 2018-12-31 |
| 00855106005325 - LINX Reflux Management System | 2018-12-31 |
| 00855106005332 - LINX Reflux Management System | 2018-12-31 |
| 00855106005349 - LINX Reflux Management System | 2018-12-31 |
| 00855106005356 - LINX Reflux Management System | 2018-12-31 |
| 00855106005363 - LINX Reflux Management System | 2018-12-31 |