DEVICE: XXL™ Esophageal (08714729163053)

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Device Record History
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Device Identifier (DI) Information
XXL™ Esophageal
M001145510
In Commercial Distribution

BOSTON SCIENTIFIC CORPORATION
08714729163053
GS1

1
021717889 *Terms of Use
Balloon Dilatation Catheter
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
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?
34915 Oesophageal balloon catheter
A long, flexible device with an inflatable balloon(s) at its distal end designed to access the length of the oesophagus of adult and adolescent patients to dilate strictures through balloon inflation. It is typically constructed as a catheter of various designs and is usually used endoscopically to enable visualization during the procedure. It is typically used to dilate strictures due to oesophageal surgery, primary gastric reflux, radiation therapy, and dilatation of the cardia in patients with achalasia (failure to relax the lower oesophageal sphincter). This is a single-use device.
Obsolete 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

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Size Type Text
Device Size Text, specify: 16 mm Diameter
Device Size Text, specify: 120 cm Effective Length
Device Size Text, specify: 2 cm Length
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Device Record Status
88eb15ca-a3e7-4483-b4d0-df41d2f487a4
March 29, 2018
2
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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