Identity
- Trade Name
- CAPTIFLEX™ EUDAMEDCAPTIFLEX FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
- Device Name
- Captiflex Single-Use Polypectomy Snare EUDAMEDSingle-Use Polypectomy Snare FDA UDI
- Model / Reference
- M00562400 EUDAMEDFDA UDI
- Description
- Single-Use Polypectomy Snare FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729747932 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000049MW EUDAMED
- FDA Product Code
- FDI FDA UDI
- EMDN Code
- G03030102 POLYPECTOMY SNARES, NON-REVOLVING EUDAMED
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4300 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Endoscopic electrosurgical handpiece/electrode, monopolar, single-useMechanical-cutting endoscopic polypectomy snare
Captiflex by Boston Scientific — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Mechanical-cutting endoscopic polypectomy snare.
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- Multiple Loop Polypectomy Snare — Avanos Medical, Inc. · Class II
- Lasso — Diversatek Healthcare · Class I
- Cold Snare — Micro-Tech (Nanjing) Co., Ltd. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific
Sources (2)
- FDA UDI 2f951301-21e7-46f9-8c6b-804d3217c23f 34 fields · synced Jun 18, 2026
- EUDAMED 01e84750-a26d-4b9d-8972-6f677028cbc1 61 fields · synced Jun 4, 2026