Identity
- Trade Name
- iSnare FDA UDI
- Generic Name
- Endoscopic electrosurgical submucosal lift/resection set FDA UDI
- Device Name
- The iSnare hexagonal system is a dual lumen device providing both needle injection and monopolar electrocautery polypectomy snare capability within a single catheter device. FDA UDI
- Model / Reference
- 00711088 FDA UDI
- Description
- The iSnare hexagonal system is a dual lumen device providing both needle injection and monopolar electrocautery polypectomy snare capability within a single catheter device. FDA UDI
Identifiers
- Catalog Number
- 00711088 FDA UDI
- Primary DI / UDI-DI
- 00816765010938 FDA UDI
- FDA Product Code
- FDI FDA UDIFBK FDA UDI
- GMDN Term
- Endoscopic electrosurgical submucosal lift/resection set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4300 FDA UDI876.1500 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 230 Centimeter FDA UDIWidth — 2.5 Millimeter FDA UDINeedle Gauge — 25 Gauge FDA UDI
iSnare by US Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- US Endoscopy
Sources (1)
- FDA UDI 85959ad9-eb64-4800-8072-0c980e26a884 38 fields · synced May 29, 2026