BougieCap 400.32.01

GUDID 04260206310853

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

Ovesco Endoscopy AG

Endoscopic gastrointestinal stenosis dilator
Primary Device ID04260206310853
NIH Device Record Key1f678935-682d-4106-b226-dffe0873cfa9
Commercial Distribution StatusIn Commercial Distribution
Brand NameBougieCap
Version Model Number12
Catalog Number400.32.01
Company DUNS344007369
Company NameOvesco Endoscopy AG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+19196519449
Emailcustomerservice@ovesco-usa.com
Phone+19196519449
Emailcustomerservice@ovesco-usa.com
Phone+19196519449
Emailcustomerservice@ovesco-usa.com
Phone+19196519449
Emailcustomerservice@ovesco-usa.com
Phone+19196519449
Emailcustomerservice@ovesco-usa.com
Phone+19196519449
Emailcustomerservice@ovesco-usa.com
Phone+19196519449
Emailcustomerservice@ovesco-usa.com
Phone+19196519449
Emailcustomerservice@ovesco-usa.com
Phone+19196519449
Emailcustomerservice@ovesco-usa.com
Phone+19196519449
Emailcustomerservice@ovesco-usa.com
Phone+19196519449
Emailcustomerservice@ovesco-usa.com
Phone+19196519449
Emailcustomerservice@ovesco-usa.com
Phone+19196519449
Emailcustomerservice@ovesco-usa.com
Phone+19196519449
Emailcustomerservice@ovesco-usa.com
Phone+19196519449
Emailcustomerservice@ovesco-usa.com
Phone+19196519449
Emailcustomerservice@ovesco-usa.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter12 Millimeter
Length26.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter12 Millimeter
Length26.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter12 Millimeter
Length26.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter12 Millimeter
Length26.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter12 Millimeter
Length26.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter12 Millimeter
Length26.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter12 Millimeter
Length26.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter12 Millimeter
Length26.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter12 Millimeter
Length26.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter12 Millimeter
Length26.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter12 Millimeter
Length26.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter12 Millimeter
Length26.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter12 Millimeter
Length26.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter12 Millimeter
Length26.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter12 Millimeter
Length26.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104260206310853 [Package]
Contains: 04260206310860
Package: folding box [3 Units]
In Commercial Distribution
GS104260206310860 [Primary]

FDA Product Code

KNQDilator, Esophageal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-10-31
Device Publish Date2018-10-05

On-Brand Devices [BougieCap]

04260206310891The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transp
04260206310877The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transp
04260206310853The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transp
04260206310839The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transp
04260206310815The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transp
04260206310792The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transp
04260206311478The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transp
04260206311454The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transp
04260206311430The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transp
04260206311416The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transp
04260206311393The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transp
04260206311379The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transp
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