FDA UDI
In Commercial Distribution
🇺🇸 United States
Stone Extraction Balloon
DI: 06970057571027
·
Model: VDK-BAL-23-11/13/15-B
·
Jiangsu Vedkang Medical Science and Technology Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Stone Extraction Balloon
- Primary DI
- 06970057571027
- Version / Model
- VDK-BAL-23-11/13/15-B
- Company Name
- Jiangsu Vedkang Medical Science and Technology Co.,Ltd.
- Labeler DUNS
- 544430136
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-14
- Public Version
- 1
- Public Version Date
- 2026-04-22
- Public Version Status
- New
- Public Device Record Key
- 3f4ad9da-b6d6-4e1f-9835-776607a3de00
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
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | Gastroenterology, Urology | 876.5010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46715 | ERCP catheter, balloon, non-electrical, stone-retrieval | A flexible, tubular, non-electrical device with an inflatable multi-sizing balloon at the distal end designed for the removal of stones (calculi) from the biliary tract during endoscopic retrograde cholangiopancreatography (ERCP). It is inserted through the working channel of an endoscope, typically beyond the stones, where the balloon is inflated and retracted to push the stones out. It typically has more than one lumen to allow, e.g., use of a guidewire while simultaneously enabling the injection of a contrast medium into the biliary tree for fluoroscopic visualization of the bile ducts. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 26970057571021 | GS1 | box | 2 | In Commercial Distribution | |
| Primary | 06970057571027 | GS1 | ||||
| Package | 56970057571022 | GS1 | carton | 20 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232752 | 000 |