Identity
- Trade Name
- colonic FTRD prOVE Cap FDA UDI
- Generic Name
- Endoscopic electrosurgical biopsy/resection cap trial FDA UDI
- Device Name
- FTRD application cap for verification of possible application of the colonic FTRD (accessability and ability to pull lesion into the cap). FDA UDI
- Model / Reference
- FTRD 14 FDA UDI
- Description
- FTRD application cap for verification of possible application of the colonic FTRD (accessability and ability to pull lesion into the cap). FDA UDI
Identifiers
- Catalog Number
- 200.71 FDA UDI
- Primary DI / UDI-DI
- 04260206311157 FDA UDI
- FDA Product Code
- FEI FDA UDI
- GMDN Term
- Endoscopic electrosurgical biopsy/resection cap trial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.1500 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscopic electrosurgical biopsy/resection cap trial
colonic FTRD prOVE Cap by Ovesco Endoscopy AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electrosurgical biopsy/resection cap trial.
- gastroduodenal FTRD prOVE Cap — Ovesco Endoscopy AG · Class I
- FTRD prOVE Cap — Ovesco Endoscopy AG · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Ovesco Endoscopy AG
Sources (1)
- FDA UDI 8c2c5887-a2d9-4dad-a574-b4ffae4d8ff4 36 fields · synced May 30, 2026