Identity
- Trade Name
- Resolution™ EUDAMEDResolution Clip FDA UDI
- Generic Name
- Gastrointestinal endoscopic clip, long-term, non-bioabsorbable FDA UDI
- Device Name
- Resolution Clip EUDAMEDClipping Device FDA UDI
- Model / Reference
- M00522610 EUDAMEDFDA UDI
- Description
- Clipping Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729504795 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000338N8 EUDAMED
- FDA Product Code
- PKL FDA UDI
- EMDN Code
- G030202 DIGESTIVE ENDOSCOPY, HAEMOSTASIS CLIPS EUDAMED
- GMDN Term
- Gastrointestinal endoscopic clip, long-term, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4400 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
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: Gastrointestinal endoscopic clip, long-term, non-bioabsorbable
Resolution Clip by Boston Scientific — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 e62efd6d-3ae4-4f71-9543-98161d8806e2 34 fields · synced Jul 19, 2026
- EUDAMED 7df4965f-0b21-47a0-9ea0-c01fc2709b80 61 fields · synced Jul 19, 2026