FDA UDI
In Commercial Distribution
🇺🇸 United States
Extraction Basket
DI: 06932503511605
·
Model: RSEB-H4-20
·
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
- Extraction Basket
- Primary DI
- 06932503511605
- Version / Model
- RSEB-H4-20
- 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
- 2025-04-28
- Public Version
- 2
- Public Version Date
- 2025-12-02
- Public Version Status
- Update
- Public Device Record Key
- 0063263e-f501-400c-b570-d93e7cce7a6a
Device Description
Basket shape: Four wires Hexagonal; Basket Diameter: 20mm; Basket Length: 45mm; 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
- 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
- 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 |
|---|---|---|---|---|
| LQR | Dislodger, Stone, Biliary | Gastroenterology, Urology | 876.5010 | 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 | 16932503511602 | GS1 | BOX | 2 | In Commercial Distribution | |
| Primary | 06932503511605 | GS1 | ||||
| Package | 26932503511609 | GS1 | CASE | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 877-552-4027
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243471 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 2000 | Millimeter | |
| Outer Diameter | 20 | Millimeter |