| Primary Device ID | 00810805000224 |
| NIH Device Record Key | a035b6b7-ec56-40f2-b296-2fd306412737 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StarGuard Suture Retention Plates - 7" |
| Version Model Number | SG-7 |
| Company DUNS | 090266979 |
| Company Name | PRESERVATION SOLUTIONS INC |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 2627236715 |
| brader@preservationsolutions.com | |
| Phone | 2627236715 |
| brader@preservationsolutions.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810805000224 [Primary] |
| KGS | Retention Device, Suture |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-01-07 |
| Device Publish Date | 2018-12-07 |
| 00810805000224 - StarGuard Suture Retention Plates - 7" | 2019-01-07For the temporary, external anchoring of sutures and prevention of suture pull through. |
| 00810805000224 - StarGuard Suture Retention Plates - 7" | 2019-01-07 For the temporary, external anchoring of sutures and prevention of suture pull through. |
| 00810805000231 - StarGuard Suture Retention Plates - 9" | 2019-01-07 For the temporary, external anchoring of sutures and prevention of suture pull through. |
| 10810805000092 - Belzer MPS (UW Machine Perfusion Solution ) | 2018-07-06 Formulated for the in-vitro flushing and continuous hypothermic machine perfusion preservation of explanted kidneys. 1000 mL |
| 10810805000108 - Belzer MPS (UW Machine Perfusion Solution ) | 2018-07-06 Formulated for the in-vitro flushing and continuous hypothermic machine perfusion preservation of explanted kidneys. 1000 mL |
| 10810805000177 - Waters IGL Pulsatile Perfusion Solution | 2018-07-06 Formulated for the in-vitro flushing and continuous hypothermic machine perfusion preservation of explanted kidneys. 1000 mL |
| 00810805000187 - Wittmann Patch | 2018-07-06 For temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are nece |
| 00810805000194 - XTAC | 2018-07-06 For temporary bridging of fascial defects where primary closure is not possible, including but not limited to, abdominal compart |
| 10810805000023 - Belzer UW Cold Storage Solution | 2018-03-29 Formulated for flushing and cold storage of kidney, liver and pancreas organs. 500 mL |