Stradis
- Primary DI
- M752FG20FACC0
- Brand
- Stradis
- Company
- STRADIS MEDICAL, LLC
- Model
- FG-20F-ACC
- Device description
- PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG)
- Published
- 2022-09-12
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| PRX | Gastrostomy Guide Wire Placement Kit |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| PRX | Gastrostomy Guide Wire Placement Kit | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| M752FG20FACC0 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| General surgical procedure kit, medicated | A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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