FDA UDI
In Commercial Distribution
🇺🇸 United States
Polypectomy Snare
DI: 06974173020780
·
Model: MD-E-SNC241018
·
Zhejiang Chuangxiang Medical Technology Co., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Polypectomy Snare
- Primary DI
- 06974173020780
- Version / Model
- MD-E-SNC241018
- Company Name
- Zhejiang Chuangxiang Medical Technology Co., LTD.
- Labeler DUNS
- 544434963
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-10
- Public Version
- 2
- Public Version Date
- 2022-07-18
- Public Version Status
- Update
- Public Device Record Key
- 9db8f5e8-1c53-4316-9bc1-d899887d3981
Device Description
NON-ELECTRICAL
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
- No
- 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 | 16974173020008 | GS1 | box | 10 | In Commercial Distribution | |
| Primary | 06974173020780 | GS1 | ||||
| Package | 26974173020005 | GS1 | Case | 5 | In Commercial Distribution |