DEVICE: Maverick²™ (08714729370154)

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Device Record History
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Device Identifier (DI) Information
Maverick²™
H7493892820150
In Commercial Distribution

BOSTON SCIENTIFIC CORPORATION
08714729370154
GS1

1
021717889 *Terms of Use
PTCA 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?
47732 Coronary angioplasty balloon catheter, basic
A flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LOX Catheters, transluminal coronary angioplasty, percutaneous
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P860019 179
P860019 191
P860019 202
P860019 203
P860019 205
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: 20 mm Length
Device Size Text, specify: 1.5 mm Diameter
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Device Record Status
3e955102-b3b3-49cd-bed5-b5a14331001c
October 07, 2019
4
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

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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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