| Primary Device ID | 37613154170983 |
| NIH Device Record Key | 89075137-a099-4cd1-8ab0-b29d80b199a0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Revolution |
| Version Model Number | 0606520000 |
| Catalog Number | 0606520000 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613154170982 [Primary] |
| GS1 | 37613154170983 [Package] Contains: 07613154170982 Package: pack [6 Units] In Commercial Distribution |
| JDZ | MIXER, CEMENT, FOR CLINICAL USE |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-25 |
| Device Publish Date | 2018-09-24 |
| 37613252722701 | Full Core Biopsy Device |
| 37613154354390 | Cement Mixing System with Femoral Breakaway Nozzle, Medium Solid Proximal Pressurizer, Revision |
| 37613154170983 | MIS Breakaway Nozzle |
| 37613154169697 | Cement Mixing System with MIS Femoral Breakaway Nozzle and Advanced Femoral Canal Pressurizer (M |
| 37613154169673 | Cement Mixing System with MIS Femoral Breakaway Nozzle |
| 37613154169666 | Cement Mixing System with Nozzle |
| 34546540912344 | Cement Mixing System with Femoral Breakaway Nozzle, Medium Solid Proximal Pressurizer, Universal |
| 34546540912115 | Cement Mixing System with Femoral Breakway Nozzle and Medium Pressurizer |
| 34546540912092 | Cement Mixing System with Femoral Breakway Nozzle |
| 34546540911972 | Tibial Nozzle |
| 34546540447914 | Cement Mixing System with Femoral Breakaway Nozzle and Advanced Femoral Canal Pressurizer (Mediu |
| 34546540447907 | Cement Mixing System with Cancellous Nozzle and Tibial Pressurizer Tip |
| 34546540447891 | Cement Mixing System without Nozzle |
| 34546540447877 | Cancellous Nozzle with Pressurizer Kit |
| 34546540447860 | Syringe Tip Nozzle |
| 34546540447846 | Thin Flexible Nozzle |
| 34546540447839 | Femoral Pressurizer Nozzle |
| 34546540447822 | Breakaway Nozzle |
| 34546540447815 | Humeral Nozzle |
| 04546540437037 | Cement Gun |