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BougieCap

FDA UDI

Class II (US FDA UDI)

by Ovesco Endoscopy AG

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 • tapered design allowing precise dilation in millimetre increments • 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
7/8 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 • tapered design allowing precise dilation in millimetre increments • 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
400.31.02 FDA UDI
Primary DI / UDI-DI
04260206311386 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
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
Length — 19.5 Millimeter FDA UDI

Category: Endoscopic gastrointestinal stenosis dilator

BougieCap by Ovesco Endoscopy AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic gastrointestinal stenosis dilator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ovesco Endoscopy AG

Sources (1)

  • FDA UDI c7df4327-4eec-4a2d-8143-93b90f6a622a 36 fields · synced May 30, 2026