| Primary Device ID | 37613327419031 | 
| NIH Device Record Key | 773e1b02-5f2a-4dbc-b192-1c9922f76643 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Pivot Guardian | 
| Version Model Number | 3105000732 | 
| Catalog Number | 3105-000-732 | 
| 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 | 07613327419030 [Primary] | 
| GS1 | 37613327419031 [Package] Contains: 07613327419030 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 |