| Primary Device ID | M752991014505 |
| NIH Device Record Key | 50515276-995a-47bd-a71e-96b63c5c2b9d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stradis Medical, LLC |
| Version Model Number | 99-10-1450 |
| Company DUNS | 174262477 |
| Company Name | STRADIS MEDICAL, LLC |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-424-8520 |
| cs@stradishealthcare.com | |
| Phone | 1-800-424-8520 |
| cs@stradishealthcare.com | |
| Phone | 1-800-424-8520 |
| cs@stradishealthcare.com | |
| Phone | 1-800-424-8520 |
| cs@stradishealthcare.com | |
| Phone | 1-800-424-8520 |
| cs@stradishealthcare.com | |
| Phone | 1-800-424-8520 |
| cs@stradishealthcare.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M752991014500 [Primary] |
| HIBCC | M752991014505 [Package] Contains: M752991014500 Package: outer box [50 Units] In Commercial Distribution |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-11-06 |
| Device Publish Date | 2018-11-12 |
| M752IM12615 | IV Start Kit |
| M752IM12595 | Dressing Change kit w/Sorbaview |
| M752TMDCIP35 | Dressing Change Tray |
| M752682HOSE1 | Compression Hose Kit |
| M752HCT20505 | 50 mL EVA Bags, 2 Port |
| M752HCT202505 | 250 mL EVA Bags, 2 Port |
| M752HCT201005 | 100 mL EVA Bags, 2 Port |
| M752IM1207C5 | IV Start Kit |
| M752IM1205C5 | IV Start Kit |
| M752IM1200C5 | IV Start Kit |
| M752HCT6186CP0 | Prep Kit |
| M752IM12085 | IV Start Kit With Securement |
| M752VA2015 | Lidocaine Supplement Kit |
| M752TRNRSS36605 | Ready Sharp DEXAMETHASONE |
| M752EAL30015 | Sterile PVP |
| M752DC51350 | PICC Accessory Kit |
| M752991060025 | Instrument Kit |
| M752991023705 | Tissue Forceps |
| M752991017505 | Kelly Forceps |
| M752991017305 | Mosquito Forceps |
| M752991015831 | Nail Nipper |
| M752991014605 | Iris Scissors |
| M752991014505 | Iris Scissors |
| M752991011305 | Dressing Scissors |
| M752991010505 | Lister Bandage Scissors |
| M7524779445 | Laceration Tray |
| M752VA1015 | Dressing Change Tray |
| M752TMDCSA15 | Dressing Change Tray W/CHG |
| M752TMDCMSP15 | Dressing Change Tray |
| M752TMDCIP25 | Dressing Change Tray |
| M752TMDCIP10 | Dressing Change Tray W/CHG |
| M752TMDC10005 | Dressing Change Tray W/CHG |
| M752TMBPMSP15 | Biopatch 1450 Kit |
| M752TM9538CP5 | Port PICC Access Tray |
| M752TM7522CP5 | Dressing Change Tray W/CHG |
| M752TM7296CP5 | Dressing Change Tray |
| M752TM69815 | Dressing Change Tray W/CHG |
| M752TM187995 | PICC Dressing Change W/TEG CHG |
| M752TM16585 | Dressing Change Tray |
| M752RWMDCTSORIS5 | Dressing Change Tray |
| M752RWMDCTSOR5 | Dressing Change Tray |
| M752RWMDCTLAMIS5 | Dressing Change Tray |
| M752RWMDC57F5 | Dressing Change Tray |
| M752PMDC2000C5 | Dressing Change Tray |
| M752MM8515CP15 | Central Line Dressing Change Tray |
| M752IM22125 | Dressing Change Tray W/ CHG One Step |
| M752IM12455 | Dressing Change Tray W/ ChloraPrep® |
| M752IM12195 | Dressing Change Kit |
| M752IM121815 | Dressing Change Tray |
| M752IM12185 | Dressing Change Tray |