| 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 |
| 07613327006094 - ARIA | 2025-03-10 ANCHORING PIN DRIVER |
| 07613327262865 - XIA | 2025-03-10 FORCEPS FOR MAC CONNECTOR |
| 07613327262889 - XIA II | 2025-03-10 ROD ROTATION FORCEPS |
| 07613327263169 - XIA II | 2025-03-10 POLYAXIAL SCREWDRIVER, XIA 3 STYLE |
| 07613327263237 - XIA II | 2025-03-10 SHAFT FOR POLYAXIAL SCREWDRIVER XIA 3 STYLE |
| 07613327266887 - MANTIS | 2025-03-10 TORQUE WRENCH |
| 07613327267044 - MANTIS Redux | 2025-03-10 SHAFT FOR POLYAXIAL SCREWDRIVER |
| 07613327267785 - AVS | 2025-03-10 AL SPACER IMPACTOR STRAIGHT |