FDA UDI
In Commercial Distribution
🇺🇸 United States
EdgeHog(TM) Polypectomy Snare
DI: 06932503551243
·
Model: NRPFS04-01523180
·
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
- EdgeHog(TM) Polypectomy Snare
- Primary DI
- 06932503551243
- Version / Model
- NRPFS04-01523180
- 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
- 2021-12-31
- Public Version
- 6
- Public Version Date
- 2025-12-02
- Public Version Status
- Update
- Public Device Record Key
- 07700ef6-3c9f-4ec1-a5ab-6b272facf115
Device Description
Double color handle,Oval(big flat wire),Diameter is 15 mm,outer diameter is 7Fr,working length is 1800mm,Rotatable
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 |
|---|---|---|---|---|
| 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 | 16932503551240 | GS1 | BOX | 10 | In Commercial Distribution | |
| Primary | 06932503551243 | GS1 | ||||
| Package | 26932503551247 | GS1 | CASE | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 877-552-4027
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150316 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 180 | Centimeter | |
| Outer Diameter | 2.3 | Millimeter |