Identity
- Trade Name
- BougieCap FDA UDI
- Generic Name
- Endoscopic gastrointestinal stenosis dilator FDA UDI
- Device Name
- The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual control during the dilation • the tension on the tissue is visible while passing the stricture, thereby avoiding overstretching • reduced procedure time due to less intrument change • evaluation can be done directly after the dilation thanks to the attached transparent cap • two lateral holes for air insufflation and suction • one centered hole for the insertion of a guide wire FDA UDI
- Model / Reference
- 16 FDA UDI
- Description
- The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual control during the dilation • the tension on the tissue is visible while passing the stricture, thereby avoiding overstretching • reduced procedure time due to less intrument change • evaluation can be done directly after the dilation thanks to the attached transparent cap • two lateral holes for air insufflation and suction • one centered hole for the insertion of a guide wire FDA UDI
Identifiers
- Catalog Number
- 400.32.03 FDA UDI
- Primary DI / UDI-DI
- 04260206310907 FDA UDI
- FDA Product Code
- KNQ FDA UDI
- GMDN Term
- Endoscopic gastrointestinal stenosis dilator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5365 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
Yes
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 — 16 Millimeter FDA UDILength — 33.8 Millimeter FDA UDI
BougieCap by Ovesco Endoscopy AG — 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
- Ovesco Endoscopy AG
Sources (1)
- FDA UDI e119473a-c808-48e8-b832-599d4ead03b0 37 fields · synced May 30, 2026