Identity
- Trade Name
- OTSG Xcavator FDA UDI
- Generic Name
- Endoscope tissue removal cap, single-use FDA UDI
- Device Name
- The OTSG Xcavator is an endoscopic attachment cap for flexible endoscopy that can grasp large volume of tissue or foreign bodies • for use with standard flexible endoscopes • allows for the use of additional endoscopic instruments or a guide wire through the working channel of the endoscope • flexible shaft • includes an endoscope sleeve and appropriate adhesive tapes FDA UDI
- Model / Reference
- Xcavator FDA UDI
- Description
- The OTSG Xcavator is an endoscopic attachment cap for flexible endoscopy that can grasp large volume of tissue or foreign bodies • for use with standard flexible endoscopes • allows for the use of additional endoscopic instruments or a guide wire through the working channel of the endoscope • flexible shaft • includes an endoscope sleeve and appropriate adhesive tapes FDA UDI
Identifiers
- Catalog Number
- 200.15 FDA UDI
- Primary DI / UDI-DI
- 04260206311317 FDA UDI
- FDA Product Code
- KOA FDA UDI
- GMDN Term
- Endoscope tissue removal cap, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4730 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
MR Conditional FDA UDI
Category: Endoscope tissue removal cap, single-use
OTSG Xcavator by Ovesco Endoscopy AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope tissue removal cap, single-use.
- Reveal — US Endoscopy · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- Reveal — US Endoscopy · Class II
- Reveal — US Endoscopy · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- Barrx — Covidien LP · 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ovesco Endoscopy AG
Sources (1)
- FDA UDI fa9fe366-4bce-4524-b353-d26198f35e17 36 fields · synced May 30, 2026