| Primary Device ID | 37613154687160 |
| NIH Device Record Key | 87cf83b8-134f-4032-b7ff-2577669f7381 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AutoPlex, VertaPlex |
| Version Model Number | 0605687000 |
| Catalog Number | 0605-687-000 |
| Company DUNS | 196548481 |
| Company Name | STRYKER CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613154687169 [Primary] |
| GS1 | 37613154687160 [Package] Contains: 07613154687169 Package: pack [2 Units] In Commercial Distribution |
| LOD | BONE CEMENT |
| NDN | CEMENT, BONE, VERTEBROPLASTY |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-07-22 |
| Device Publish Date | 2016-12-29 |
| 37613252039250 | System without Needles with HV Bone Cement |
| 37613154687160 | System without Needles with Bone Cement |
| 37613154687153 | System with Needle and Bone Cement |
| 37613154687146 | System with Needle and Bone Cement |