FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 06932503552011
·
Model: NPFS01-11523230
·
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
- NA
- Primary DI
- 06932503552011
- Version / Model
- NPFS01-11523230
- Catalog Number
- NPFS01-11523230
- Company Name
- Micro-Tech (Nanjing) Co., Ltd.
- Labeler DUNS
- 530269083
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-06
- Public Version
- 4
- Public Version Date
- 2025-11-24
- Public Version Status
- Update
- Public Device Record Key
- 0abee0d3-eb9f-49bc-9007-b2a9bda1d2be
- Distribution End Date
- 2024-07-31
Device Description
Double color handle, hexagonal, 3 * 3 wire,Diameter is 15 mm,outer diameter is 7Fr,working length is 2300mm
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 | 26932503552015 | GS1 | case | 10 | Not in Commercial Distribution | 2024-07-31 |
| Package | 16932503552018 | GS1 | box | 10 | Not in Commercial Distribution | 2024-07-31 |
| Primary | 06932503552011 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150316 | 000 |