| Primary Device ID | 07613154368167 |
| NIH Device Record Key | d799ffea-f8c3-4839-9ad3-9826bd147a35 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 0400675000 |
| Catalog Number | 0400675000 |
| 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 | 07613154368167 [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 |
| 07613327272246 - ARIA | 2025-09-25 IMPLANT IMPACTOR |
| 37613327405317 - SurgiCount Safety-Sponge | 2025-09-16 Laparotomy Sponge |
| 07613327262209 - XIA | 2025-09-11 FRENCH BENDER |
| 07613327262216 - XIA | 2025-09-11 SPREADER |
| 07613327262254 - XIA | 2025-09-11 COMPRESSOR |
| 07613327262261 - XIA | 2025-09-11 BLUNT PROBE |
| 07613327262292 - XIA | 2025-09-11 TORQUE WRENCH |
| 07613327262414 - XIA | 2025-09-11 STANDARD T-HANDLE |