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
- 00711089 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
- 00711089 FDA UDI
- Primary DI / UDI-DI
- 00816765010945 FDA UDI
- FDA Product Code
- FBK FDA UDIFDI FDA UDI
- GMDN Term
- Endoscopic electrosurgical submucosal lift/resection set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI876.4300 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
- Needle Gauge — 23 Gauge FDA UDILength — 230 Centimeter FDA UDIWidth — 2.5 Millimeter 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 161268de-d29c-4420-8cf5-c3e8bdbf367b 38 fields · synced May 30, 2026