Duns Number:344007369
Device Description: The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the tr 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
Catalog Number
400.32.03
Brand Name
BougieCap
Version/Model Number
16
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 2022
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KNQ
Product Code Name
Dilator, Esophageal
Public Device Record Key
e119473a-c808-48e8-b832-599d4ead03b0
Public Version Date
September 30, 2022
Public Version Number
3
DI Record Publish Date
October 05, 2018
Package DI Number
04260206310891
Quantity per Package
3
Contains DI Package
04260206310907
Package Discontinue Date
September 30, 2022
Package Status
Not in Commercial Distribution
Package Type
folding box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 61 |