Identity
- Trade Name
- Polyp Pak FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
- Device Name
- The Polyp Pak includes 1 Rotator snare - oval and 1 Roth Net retriever - polyp. The Rotator snare is an electrosurgical device used to grasp, dissect and transect tissue during gastrointestinal endoscopic procedures, and used with diathermic energy. The Roth Net retriever is used in the endoscopic retrieval of foreign body, food bolus and excised tissue such as polyps. FDA UDI
- Model / Reference
- 00711091 FDA UDI
- Description
- The Polyp Pak includes 1 Rotator snare - oval and 1 Roth Net retriever - polyp. The Rotator snare is an electrosurgical device used to grasp, dissect and transect tissue during gastrointestinal endoscopic procedures, and used with diathermic energy. The Roth Net retriever is used in the endoscopic retrieval of foreign body, food bolus and excised tissue such as polyps. FDA UDI
Identifiers
- Catalog Number
- 00711091 FDA UDI
- Primary DI / UDI-DI
- 00724995182540 FDA UDI
- FDA Product Code
- FDI FDA UDI
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Category: Endoscopic electrosurgical handpiece/electrode, monopolar, single-useGastrointestinal/airway foreign body retrieval basket, single-use
Polyp Pak by US Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastrointestinal/airway foreign body retrieval basket, single-use.
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- EndoTBasket — ENDO-THERAPEUTICS, INC. · Class II
- EndoTBasket — ENDO-THERAPEUTICS, INC. · 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 63a33f70-5df3-4111-a43c-f4bb2e1ff52c 36 fields · synced Jun 1, 2026