Identity
- Trade Name
- iSnare FDA UDI
- Generic Name
- Endoscopic electrosurgical submucosal lift/resection set FDA UDI
- Device Name
- The iSnare system-Lariat snare is used to inject various types of media and to grasp, dissect and transect tissue during gastrointestinal endoscopy procedures, and can be used with or without monopolar diathermic energy. FDA UDI
- Model / Reference
- 00711084 FDA UDI
- Description
- The iSnare system-Lariat snare is used to inject various types of media and to grasp, dissect and transect tissue during gastrointestinal endoscopy procedures, and can be used with or without monopolar diathermic energy. FDA UDI
Identifiers
- Catalog Number
- 00711084 FDA UDI
- Primary DI / UDI-DI
- 00724995180782 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
- 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
- Outer Diameter — 2.5 Millimeter FDA UDIWidth — 30 Millimeter FDA UDINeedle Gauge — 25 Gauge FDA UDILength — 230 Centimeter FDA UDI
Category: Endoscopic electrosurgical submucosal lift/resection set
iSnare by US Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endoscopic electrosurgical submucosal lift/resection set.
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- DISPOSABLE EMR KIT — Olympus Medical Systems Corporation · Class II
- DISPOSABLE EMR KIT — Olympus Medical Systems Corporation · Class II
- DISPOSABLE EMR KIT — Olympus Medical Systems Corporation · Class II
- DISPOSABLE EMR KIT — Olympus Medical Systems Corporation · Class II
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 f567ea5b-1761-4cb4-acc5-7112ca6128e6 37 fields · synced May 30, 2026