FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable Cold Snares
DI: 06970057577470
·
Model: VDK-CS-23-230-10-C3R
·
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
- Disposable Cold Snares
- Primary DI
- 06970057577470
- Version / Model
- VDK-CS-23-230-10-C3R
- 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
- 2024-08-17
- Public Version
- 3
- Public Version Date
- 2025-01-08
- Public Version Status
- Update
- Public Device Record Key
- a0e021e2-209b-4849-8d4d-a0781c10dc9b
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
- Yes
- 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 |
|---|---|---|---|---|
| FGX | Snare, Non-Electrical | Gastroenterology, Urology | 876.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62615 | Mechanical-cutting endoscopic polypectomy snare | A sterile, flexible, non-powered (i.e., not electrosurgical) device intended to be inserted through an endoscope to ensnare and cut polyps or other mucosal lesions during endoscopic surgery. It typically consists of a flexible sheath with a sharp cutting snare loop attached to the distal end of the sheath, and a handle which mechanically controls snaring through manual action. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16970057577477 | GS1 | BOX | 10 | In Commercial Distribution | |
| Primary | 06970057577470 | GS1 | ||||
| Package | 56970057577475 | GS1 | carton | 5 | In Commercial Distribution |