| Primary Device ID | 04046963976781 |
| NIH Device Record Key | d635f14b-7eaa-4030-8834-0584e7bf292f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | S4 |
| Version Model Number | SW821T |
| Catalog Number | SW821T |
| Company DUNS | 315018218 |
| Company Name | Aesculap AG |
| 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 | 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 | 04046963976781 [Primary] |
| NKB | Orthosis, spinal pedicle fixation, for degenerative disc disease |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2024-08-21 |
| Device Publish Date | 2015-09-24 |
| 04046963460280 | S4 STRAIGHT ROD 5.5X500MM HEXAG.TIP |
| 04038653405268 | S4 LAMINA HOOK 10MM LEFT |
| 04046963460242 | S4 STRAIGHT ROD 5.5X180MM HEXAG.TIP |
| 04046963460235 | S4 STRAIGHT ROD 5.5X150MM HEXAG.TIP |
| 04038653400911 | S4 RIGID CROSS CONNECTOR 32MM |
| 04038653400973 | S4 ADJUSTABLE CROSS CONNECTOR 60-75MM |
| 04038653400966 | S4 ADJUSTABLE CROSS CONNECTOR 49-60MM |
| 04038653400959 | S4 ADJUSTABLE CROSS CONNECTOR 43-49MM |
| 04038653400942 | S4 RIGID CROSS CONNECTOR 41MM |
| 04038653400935 | S4 RIGID CROSS CONNECTOR 38MM |
| 04038653400928 | S4 RIGID CROSS CONNECTOR 35MM |
| 04038653400904 | S4 RIGID CROSS CONNECTOR 29MM |
| 04046963976781 | S4 PARALLEL ROD CONNECTOR D5.5/5.5MM |
| 04046963460273 | S4 STRAIGHT ROD 5.5X400MM HEXAG.TIP |
| 04046963460266 | S4 STRAIGHT ROD 5.5X300MM HEXAG.TIP |
| 04046963460259 | S4 STRAIGHT ROD 5.5X200MM HEXAG.TIP |
| 04038653405251 | S4 LAMINA HOOK 6MM RIGHT |