FDA UDI
In Commercial Distribution
🇺🇸 United States
XenX – Stone Management Device (7 cm tip Proximal Stone)
DI: 03700512965237
·
Model: ROXE03807ST
·
Promepla
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- XenX – Stone Management Device (7 cm tip Proximal Stone)
- Primary DI
- 03700512965237
- Version / Model
- ROXE03807ST
- Catalog Number
- ROXE03807ST
- Company Name
- Promepla
- Labeler DUNS
- 401020409
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-11
- Public Version
- 5
- Public Version Date
- 2020-11-06
- Public Version Status
- Update
- Public Device Record Key
- 22a1c38e-6bb8-4a6b-b634-417a71b6f7eb
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
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| 46452 | Biliary/urinary stone retrieval basket, single-use | A flexible, manual instrument designed to trap/retrieve biliary and/or urinary stones (gallbladder and/or renal/ureteric calculi) from the body during an open surgical and/or endoscopic/laparoscopic procedure [e.g., choledochoscopy, endoscopic retrograde cholangiopancreatography (ERCP)]; it is not intended to fragment/crush. It is typically designed with a long, thin, flexible shank that has an expandable basket of wire (typically metallic) at its distal end in which the stones are caught. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03700512975236 | GS1 | Box label | 1 | In Commercial Distribution | |
| Primary | 03700512965237 | GS1 |
Customer Contacts
- Phone
- +37797984232
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123438 | 000 |