STRADIS HEALTHCARE
- Primary DI
- M7526550840
- Brand
- STRADIS HEALTHCARE
- Company
- STRADIS MEDICAL, LLC
- Model
- 655-084
- Published
- 2022-03-17
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| PRW | Gastrointestinal Tube Kit |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| PRW | Gastrointestinal Tube Kit | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| M7526550841 | Package | HIBCC | 10 | In Commercial Distribution |
| M7526550840 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| General/plastic surgical procedure kit, non-medicated, single-use | A collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device. |
Regulatory Flags
- DUNS number
- 174262477
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| M7525251811 | STRADIS | 525-181 | | 2017-04-01 |
| M75257032650 | STRADIS HEALTHCARE | 570-3265 | | 2023-01-17 |
| M7529992814655 | Stradis Medical, LLC. | 999281465 | | 2018-12-13 |
| M7529992814665 | Stradis Medical, LLC. | 999281466 | | 2018-10-02 |
| M7529992814705 | Stradis Medical, LLC. | 999281470 | | 2018-12-13 |
| M7529992814715 | Stradis Medical, LLC. | 999281471 | | 2018-12-13 |
| M7529992814725 | Stradis Medical, LLC. | 999281472 | | 2018-11-21 |
| M7529992814735 | Stradis Medical, LLC. | 999281473 | | 2018-11-21 |
| M7529992814745 | Stradis Medical, LLC. | 999281474 | | 2018-11-16 |
| M7529992814755 | Stradis Medical, LLC. | 999281475 | | 2018-12-17 |
| M7529992814765 | Stradis Medical, LLC. | 999281476 | | 2018-09-27 |
| M7529992815585 | Stradis Medical, LLC. | 999281558 | | 2018-12-13 |
| M752682PREG1 | Stradis Medical, LLC | 682-PREG | | 2017-08-08 |
| M75257032000 | STRADIS HEALTHCARE | 570-3200 | | 2022-12-19 |
| M75257032180 | STRADIS HEALTHCARE | 570-3218 | | 2022-12-19 |
| M75257032310 | STRADIS HEALTHCARE | 570-3231 | | 2022-12-19 |
| M75257032380 | STRADIS HEALTHCARE | 570-3238 | | 2022-12-20 |
| M7521000125 | Stradis Medical, LLC. | 100012 | | 2018-10-08 |
| M7521000161 | Stradis Medical, LLC. | 100016 | | 2018-10-08 |
| M7521000175 | Stradis Medical, LLC | 100017 | | 2018-10-08 |
stradishealthcare.com