FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterile Biliary Stone Retrieval Balloon Catheter
DI: 06932503511209
·
Model: SRB-T-12/15/18-20-G
·
Micro-Tech (Nanjing) Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Sterile Biliary Stone Retrieval Balloon Catheter
- Primary DI
- 06932503511209
- Version / Model
- SRB-T-12/15/18-20-G
- Company Name
- Micro-Tech (Nanjing) Co., Ltd.
- Labeler DUNS
- 530269083
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-31
- Public Version
- 4
- Public Version Date
- 2025-12-22
- Public Version Status
- Update
- Public Device Record Key
- 20a342d2-7003-404f-b33c-1771505e4196
Device Description
Sterile Biliary Stone Retrieval Balloon Catheter with triple-lumen, Work diameter 12mm/15mm/18mm, Working Length 2000mm,
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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 |
|---|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 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 | 16932503511206 | GS1 | BOX | 1 | In Commercial Distribution | |
| Primary | 06932503511209 | GS1 | ||||
| Package | 26932503511203 | GS1 | CASE | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 877-552-4027
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211021 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Balloon Diameter | 12 | Millimeter | |
| Balloon Diameter | 15 | Millimeter | |
| Balloon Diameter | 18 | Millimeter | |
| Catheter Working Length | 2000 | Millimeter |