| 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 |
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| 37613327576826 - PELLO | 2024-11-21 4mm Angled 70 Degree Diamond Bur |
| 07613327579031 - PELLO | 2024-11-21 4mm Angled 15 Degree Diamond Bur |
| 07613327579055 - PELLO | 2024-11-21 4mm Angled 70 Degree Diamond Bur |
| 07613327261820 - MAC | 2024-10-29 SCREWDRIVER |
| 07613327271089 - DYNATRAN | 2024-10-29 COMPRESSOR |
| 07613327273885 - Aero-LL | 2024-10-29 INSERTER - DISTRACTOR |
| 37613327566162 - Neptune | 2024-10-23 V2 SPECIMEN COLLECTION MANIFOLD KIT |