FDA UDI
In Commercial Distribution
🇺🇸 United States
X-Filter basket
DI: 03700512968597
·
Model: ROXE363609ST
·
Promepla
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- X-Filter basket
- Primary DI
- 03700512968597
- Version / Model
- ROXE363609ST
- Catalog Number
- XF36150
- Company Name
- Promepla
- Labeler DUNS
- 401020409
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-28
- Public Version
- 1
- Public Version Date
- 2022-05-06
- Public Version Status
- New
- Public Device Record Key
- 5acda16e-e106-4245-ac75-624a2385e8a8
Device Description
Anti Migration Device
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | Gastroenterology, Urology | 876.1500 | 2 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | Gastroenterology, Urology | 876.4680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60482 | Ureteropelvic stone filtering catheter | A flexible tubular device with a non-detachable expandable filter at the distal end intended to be temporarily introduced, via the ureter or percutaneously, into the urinary tract to prevent migration/allow filtration of stone fragments during a lithotripsy procedure. It may also be used for the injection of a contrast medium for fluoroscopic visualization (i.e., retrograde pyelogram), guidance of other devices and/or drainage of fluids. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03700512978596 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 03700512968597 | GS1 | ||||
| Package | 03700512988595 | GS1 | Box | 4 | In Commercial Distribution |