DEVICE: BougieCap (04260206310808)
Device Identifier (DI) Information
BougieCap
7
Not in Commercial Distribution
400.31.01
Ovesco Endoscopy AG
7
Not in Commercial Distribution
400.31.01
Ovesco Endoscopy AG
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
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
62109 | Endoscopic gastrointestinal stenosis dilator |
A sterile invasive device intended to be used to dilate or expand a narrowing lesion (e.g., oesophageal stricture, stenosis) in the lumen of the gastrointestinal [GI] tract, under endoscopic visualization. It is made of transparent synthetic polymer material and is available in various forms (e.g., a slender hollow tube through which is passed the endoscope before introduction into the GI tract, or a tapered cap applied to the distal end of the endoscope); the dilator is advanced through the lesion site with direct visualization through the endoscope. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KNQ | Dilator, Esophageal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Outer Diameter: 7.1 Millimeter |
Length: 14.7 Millimeter |
Device Size Text, specify: for endoscopes with diameter 5.5 - 6 mm |
Device Size Text, specify: mounting depht of the cap: 5 mm |
Device Record Status
21eb7c03-74d4-4a50-8f48-9d0182c92e39
September 30, 2022
3
October 05, 2018
September 30, 2022
3
October 05, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
04260206310792 | 3 | 04260206310808 | 2022-09-30 | Not in Commercial Distribution | folding box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+19196519449
customerservice@ovesco-usa.com +49707196528160
service@ovesco.com
customerservice@ovesco-usa.com +49707196528160
service@ovesco.com