DEVICE: TREO Abdominal Stent-Graft System (08435761052098)

Device Identifier (DI) Information

TREO Abdominal Stent-Graft System
28-L2-20-100U
Not in Commercial Distribution
28-L2-20-100U
Bolton Medical Inc.
08435761052098
GS1
May 19, 2023
1
847424462 *Terms of Use
Endovascular Stent-Graft System
CLOSE

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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MIH System, Endovascular Graft, Aortic Aneurysm Treatment
CLOSE

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
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 5 and 40 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 15 Millimeter
Outer Diameter: 20 Millimeter
Length: 100 Millimeter
Catheter Gauge: 14 French
CLOSE

Device Record Status

8cf7577d-658e-47a7-affc-d515ab5c81c7
December 11, 2024
8
May 19, 2020
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE