| Primary Device ID | 37613327419024 |
| NIH Device Record Key | 42a705ed-ef7f-4e82-b8c3-533c7b5b3417 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pivot Guardian |
| Version Model Number | 3105000730 |
| Catalog Number | 3105-000-730 |
| Company DUNS | 187502109 |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| 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(866)624-4422 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613327419023 [Primary] |
| GS1 | 37613327419024 [Package] Contains: 07613327419023 Package: pack [3 Units] In Commercial Distribution |
| PXN | Basic set-up tray |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-01-07 |
| Device Publish Date | 2018-12-07 |
| 07613327419689 | 3105000201 |
| 37613327419048 | Pivot Guardian Disposable Kit, Medium |
| 37613327419031 | Pivot Guardian Disposable Kit, Large |
| 37613327419024 | Pivot Guardian Disposable Kit, Small |
| 07613327380385 | PostFree Tabletop Extension, US |
| 07613327380378 | PostFree Perineal Accessory Kit |
| 07613327380361 | PostFree Frame |
| 37613327376402 | PostFree Patient Safety Kit, Large |
| 37613327376396 | PostFree Patient Safety Kit, Medium |
| 37613327376389 | PostFree Patient Safety Kit, Small |
| 07613327575484 | 3105000303 |
| 07613327574838 | 3105000304 |
| 07613327565812 | 3105000300 |
| 07613327565782 | 3105000313 |
| 07613327565775 | 3105000301 |
| 07613327565379 | 3105000306 |
| 07613327563818 | 3105000308 |
| 37613327570480 | Pivot Guardian Direct Disposable Kit Medium |
| 37613327570473 | Pivot Guardian Direct Disposable Kit Large |
| 37613327570466 | Pivot Guardian Direct Disposable Kit Small |
| 07613327581539 | 3105000305 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PIVOT GUARDIAN 90712541 not registered Live/Pending |
Stryker Corporation 2021-05-14 |