| Primary Device ID | 04546540591654 |
| NIH Device Record Key | a2715b94-8f3a-4015-ac3d-8254c6ef822e |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 0408660000 |
| Catalog Number | 0408660000 |
| Company DUNS | 196548481 |
| Company Name | STRYKER CORPORATION |
| 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 | false |
| 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 |
| Phone | +1(800)253-3210 |
| Inst.Stryker.cs@Stryker.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04546540591654 [Primary] |
| FXZ | HELMET, SURGICAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-25 |
| Device Publish Date | 2018-09-24 |
| 37613327556460 - Neptune | 2025-02-07 SafeAir 70mm Blade Electrode, Coated, Insulated, Non-Sterile |
| 07613327624069 - Echo | 2025-02-03 Intracranial Base Catheter |
| 07613327624083 - Echo | 2025-02-03 Intracranial Base Catheter |
| 07613327624106 - Broadway 8 | 2025-02-03 Catheter |
| 37613327548205 - Neptune SafeAir | 2025-01-14 Telescopic Smoke Evacuation Pencil, Push Button, Coated, No PVC |
| 07613327273120 - TRIO | 2025-01-03 PEDICULAR SCREWDRIVER SHAFT |
| 07613327273144 - TRIO + | 2025-01-03 SELF HOLDING PEDICULAR SCREWDRIVER |
| 07613327273175 - TRIO + | 2025-01-03 FLEXIBLE EXTENDER III |