DEVICE: TREO Abdominal Stent-Graft System (08435761052067)

Device Identifier (DI) Information

TREO Abdominal Stent-Graft System
28-L2-13-100U
Not in Commercial Distribution
28-L2-13-100U
Bolton Medical Inc.
08435761052067
GS1
May 19, 2023
1
847424462 *Terms of Use
Endovascular Stent-Graft 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?
46777 Abdominal aorta endovascular stent-graft
A non-bioabsorbable tubular device typically implanted at the junction of the abdominal aorta and the common iliac arteries to reduce pressure on an abdominal aortic aneurysm (AAA) [includes aortoiliac aneurysm]; it does not contain anticoagulants or pharmaceuticals. It is percutaneously inserted via the femoral artery to the site of implantation where it self-expands. It is typically made of a metallic outer mesh structure with an inner polymer tube (endovascular graft) and is typically available as a: 1) single tube for insertion into the aorta and/or one iliac artery; or 2) two-part bifurcation design (e.g., Y-shaped tube) for insertion through both iliac arteries.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
MIH System, Endovascular Graft, Aortic Aneurysm Treatment
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P190015 000
P190015 001
P190015 002
P190015 003
P190015 004
P190015 005
P190015 006
P190015 007
P190015 008
P190015 009
P190015 010
P190015 012
P190015 013
P190015 014
P190015 017
P190015 018
P190015 019
P190015 020
P190015 021
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 5 and 40 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 15 Millimeter
Outer Diameter: 13 Millimeter
Length: 101 Millimeter
Catheter Gauge: 13 French
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Device Record Status

fe889750-b054-470e-85df-c44afec5951c
December 11, 2024
9
May 19, 2020
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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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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