FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable Polyp Snare
DI: 06970057575087
·
Model: VDK-SD-23-230-20-A1R
·
Jiangsu Vedkang Medical Science and Technology Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Disposable Polyp Snare
- Primary DI
- 06970057575087
- Version / Model
- VDK-SD-23-230-20-A1R
- 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
- 2024-08-20
- Public Version
- 2
- Public Version Date
- 2024-08-29
- Public Version Status
- Update
- Public Device Record Key
- abdebd6e-59da-4f92-8aa0-4a6382e12382
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 |
|---|---|---|---|---|
| FDI | Snare, Flexible | Gastroenterology, Urology | 876.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58039 | Endoscopic electrosurgical handpiece/electrode, monopolar, single-use | An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and requires a patient contact return electrode; it may include a suction/irrigation lumen and may feature a magnetic guidance sensor for electromagnetic tracking. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe) and may also be designed to mechanically cut tissues. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16970057575084 | GS1 | BOX | 10 | In Commercial Distribution | |
| Primary | 06970057575087 | GS1 | ||||
| Package | 56970057575082 | GS1 | carton | 5 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220089 | 000 |