DEVICE: WallFlex™ Biliary Transhepatic (08714729820550)

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Device Record History
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Device Identifier (DI) Information
WallFlex™ Biliary Transhepatic
M00574660
In Commercial Distribution

BOSTON SCIENTIFIC CORPORATION
08714729820550
GS1

1
021717889 *Terms of Use
Stent 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?
43697 Ophthalmic cryosurgical system control unit
A mains electricity-powered (AC-powered) component of an electronic ophthalmic cryosurgical system designed for the electronic control of the cryogen contained in a connected cylinder through to a connected dedicated cryogen-cooled hand-held applicator (probe). This device will typically include a user control panel that displays user information such as ?ready to use?, ?elapsed time?, ?gas pressure status? and ?applicator tip freezing indicator?. It may provide a microprocessor automated user set-up, perform electronically controlled repetitive freeze and defrost cycles.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FGE CATHETER, BILIARY, DIAGNOSTIC
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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: 10 mm Diameter
Device Size Text, specify: 40 mm Length
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Device Record Status
4cfec534-d12d-4128-a872-cc3e6b2a0937
March 29, 2018
2
September 24, 2016
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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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