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Polypectomy Snare (cold)
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref AG-5333-241518Model Normal handle (5331-5334, 5339 series)Ref AG-5339-241023Ref AG-5071-241023Model For the "hot/cold" indicated modelRef AG-5334-181018Ref AG-5072-242518Model For the "hot" indicated modelRef AG-5073-181523Ref AG-5333-181018Ref AG-5337-181018Model Rotary handle (5335-5338 series)Ref AG-50710-243223Ref AG-5074-243218Ref AG-5337-181518Ref AG-5331-181018Ref AG-5074-241018Ref AG-5337-242518Ref AG-5074-181018Ref AG-5339-241523Ref AG-5336-242523Ref AG-50710-243218Ref AG-5331-242518Ref AG-5334-241523Ref AG-5337-243218Ref AG-5333-243223Ref AG-5071-243218Ref AG-5333-181523Ref AG-5332-181518Ref AG-5336-241018Ref AG-5079-241518Ref AG-5077-241023Ref AG-5071-181523Ref AG-5076-243218Ref AG-5337-241018Ref AG-5335-243223Ref AG-5078-182518Ref AG-5333-243218Ref AG-5077-243223Ref AG-5338-241018Ref AG-5334-181023Ref AG-5076-181523Ref AG-5332-241018Ref AG-5079-241023Ref AG-5335-181518Ref AG-5336-241518Ref AG-5337-241518Ref AG-5078-243218Ref AG-5073-243223Ref AG-5339-181523Ref AG-5077-241523Ref AG-5333-242523Ref AG-5078-243223Ref AG-5071-182523Ref AG-5331-241518
Identity
- Device Name
- Polypectomy Snare (cold) EUDAMEDPolypectomy Snare EUDAMED
- Model / Reference
- Normal handle (5331-5334, 5339 series) EUDAMEDAG-5333-241518 EUDAMEDAG-5339-241023 EUDAMEDFor the "hot/cold" indicated model EUDAMEDAG-5071-241023 EUDAMEDAG-5334-181018 EUDAMEDFor the "hot" indicated model EUDAMEDAG-5072-242518 EUDAMEDAG-5073-181523 EUDAMEDAG-5333-181018 EUDAMEDRotary handle (5335-5338 series) EUDAMEDAG-5337-181018 EUDAMEDAG-50710-243223 EUDAMEDAG-5074-243218 EUDAMEDAG-5337-181518 EUDAMEDAG-5331-181018 EUDAMEDAG-5074-241018 EUDAMEDAG-5337-242518 EUDAMEDAG-5074-181018 EUDAMEDAG-5339-241523 EUDAMEDAG-5336-242523 EUDAMEDAG-50710-243218 EUDAMEDAG-5331-242518 EUDAMEDAG-5334-241523 EUDAMEDAG-5337-243218 EUDAMEDAG-5333-243223 EUDAMEDAG-5071-243218 EUDAMEDAG-5333-181523 EUDAMEDAG-5332-181518 EUDAMEDAG-5336-241018 EUDAMEDAG-5079-241518 EUDAMEDAG-5077-241023 EUDAMEDAG-5071-181523 EUDAMEDAG-5076-243218 EUDAMEDAG-5337-241018 EUDAMEDAG-5335-243223 EUDAMEDAG-5078-182518 EUDAMEDAG-5333-243218 EUDAMEDAG-5077-243223 EUDAMEDAG-5338-241018 EUDAMEDAG-5334-181023 EUDAMEDAG-5076-181523 EUDAMEDAG-5332-241018 EUDAMEDAG-5079-241023 EUDAMEDAG-5335-181518 EUDAMEDAG-5336-241518 EUDAMEDAG-5337-241518 EUDAMEDAG-5078-243218 EUDAMEDAG-5073-243223 EUDAMEDAG-5339-181523 EUDAMEDAG-5077-241523 EUDAMEDAG-5333-242523 EUDAMEDAG-5078-243223 EUDAMEDAG-5071-182523 EUDAMEDAG-5331-241518 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06959664909140 EUDAMED06959664909393 EUDAMED06959664903421 EUDAMED06959664909607 EUDAMED06959664901779 EUDAMED06959664907726 EUDAMED06959664909065 EUDAMED06959664909263 EUDAMED06959664944936 EUDAMED06959664903506 EUDAMED06959664909287 EUDAMED06959664908921 EUDAMED06959664903735 EUDAMED06959664902271 EUDAMED06959664907870 EUDAMED06959664909416 EUDAMED06959664902202 EUDAMED06959664945001 EUDAMED06959664909027 EUDAMED06959664909690 EUDAMED06959664902295 EUDAMED06959664909195 EUDAMED06959664903414 EUDAMED06959664909096 EUDAMED06959664909492 EUDAMED06959664902158 EUDAMED06959664901892 EUDAMED06959664911723 EUDAMED06959664900963 EUDAMED06959664911624 EUDAMED06959664902233 EUDAMED06959664902141 EUDAMED06959664944929 EUDAMED06959664909188 EUDAMED06959664911693 EUDAMED06959664909867 EUDAMED06959664909614 EUDAMED06959664911648 EUDAMED06959664909539 EUDAMED06959664901885 EUDAMED06959664909225 EUDAMED06959664902172 EUDAMED06959664902257 EUDAMED06959664911907 EUDAMED06959664903407 EUDAMED06959664909355 EUDAMED06959664911716 EUDAMED06959664909171 EUDAMED06959664911839 EUDAMED06959664900987 EUDAMED06959664909003 EUDAMED
- Basic UDI-DI
- 6959664953310000152 EUDAMED695966495071000015D EUDAMED695966495072000015S EUDAMED695966495332000015F EUDAMED
- EMDN Code
- G03030199 POLYPECTOMY SNARES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Polypectomy Snare (cold) is a medical device designed for the removal of polyps from the gastrointestinal tract. This device uses a snare wire to capture and excise polyp tissue, providing effective treatment for patients with polyp-related symptoms.
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221713 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K172729 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 6959664953310000152 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hangzhou AGS MedTech Co., Ltd.
- EUDAMED SRN
- CN-MF-000011718
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (52)
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