| Primary Device ID | 04546540903839 |
| NIH Device Record Key | c93b9c2b-e589-4986-96c7-c1220cb5259b |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 0400655000 |
| Catalog Number | 0400655000 |
| 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 | true |
| Manufacturing Date | false |
| 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 |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04546540903839 [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 |
| 07613327419252 - Patient Helper | 2024-12-23 |
| 37613327556651 - Neptune | 2024-12-23 SafeAir 125mm Suction Sleeve, Non-Sterile |
| 07613327643879 - Iconix | 2024-12-19 Iconix DC Guide for 2.3mm Anchor |
| 07613327643886 - Iconix | 2024-12-19 Iconix DC Obturator for 2.3 Anchor |
| 07613327644067 - Neptune | 2024-12-16 V2 SPECIMEN COLLECTION MANIFOLD |
| 07613327262469 - VBOSS | 2024-12-10 ENDPLATE TIP SMALL |
| 07613327262483 - VBOSS | 2024-12-10 ENDPLATE TIP LARGE |
| 07613327262506 - VBOSS | 2024-12-10 ENDPLATE TIP OFFSET |