DEVICE: Axios™ (08714729904595)

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Device Record History
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Device Identifier (DI) Information
Axios™
M00553650
In Commercial Distribution

BOSTON SCIENTIFIC CORPORATION
08714729904595
GS1

1
021717889 *Terms of Use
Stent and Electrocautery - Enhanced Delivery System
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Device Characteristics
MR Conditional
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?
62611 Implantable transenteric drainage tube
A non-bioabsorbable tube intended to be endoscopically implanted transmurally between the gastrointestinal (GI) tract and a pancreatic pseudocyst or the biliary tract for drainage. It is a flanged stent-like structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone). It is typically expanded in situ (e.g., with a balloon catheter or self-expands) and disposable devices to assist implantation, with or without electrosurgical functionality, may be included with the device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
PCU pancreatic stent, covered, metallic, removable
KNS Unit, electrosurgical, endoscopic (with or without accessories)
QXH Gallbladder drainage stent and delivery system
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No 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
Device Size Text, specify: 15 mm Stent Diameter
Device Size Text, specify: 10 mm Effective Length
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Device Record Status
9a7c0e41-3b72-4481-a3d0-3719371ebcb5
June 28, 2024
7
October 20, 2015
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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
No Package DIs found
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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
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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