DEVICE: BougieCap (04260206310808)

Device Identifier (DI) Information

BougieCap
7
Not in Commercial Distribution
400.31.01
Ovesco Endoscopy AG
04260206310808
GS1
September 30, 2022
1
344007369 *Terms of Use
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
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KNQ Dilator, Esophageal
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
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
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Device Record Status

21eb7c03-74d4-4a50-8f48-9d0182c92e39
September 30, 2022
3
October 05, 2018
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+19196519449
customerservice@ovesco-usa.com
+49707196528160
service@ovesco.com
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