| Primary Device ID | 07613154511105 |
| NIH Device Record Key | 950708df-f3dc-43df-ae44-d56d1e203caa |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 0400610000S3 |
| Catalog Number | 0400610000S3 |
| 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 | true |
| Serial Number | false |
| 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 Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613154511105 [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 |
| 07613327626391 - ThermaClear | 2025-04-14 |
| 07613327626407 - ThermaClear | 2025-04-14 |
| 07613327626469 - ThermaClear | 2025-04-14 |
| 07613327666601 - XpeditionTM Powered Stair Chair | 2025-03-31 Make to Stock- High Config (Grooved Tracks) |
| 07613327639032 - Broadway System | 2025-03-20 |
| 07613327639049 - Broadway System | 2025-03-20 |
| 07613327648515 - Surpass Elite | 2025-03-17 Flow Diverter System |
| 07613327648522 - Surpass Elite | 2025-03-17 Flow Diverter System |