DEVICE: Relay Plus Thoracic Stent-Graft System (00843576102309)
Device Identifier (DI) Information
Relay Plus Thoracic Stent-Graft System
28-M336190322490U
In Commercial Distribution
28-M336190322490U
Bolton Medical Inc.
28-M336190322490U
In Commercial Distribution
28-M336190322490U
Bolton Medical Inc.
Endovascular stent-graft system
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? |
---|---|---|---|---|
48060 | Descending thoracic aorta endovascular stent-graft |
A non-bioabsorbable tubular device intended to be implanted within the descending thoracic aorta to repair the vessel [includes repair of thoracic aortic aneurysm (TAA), traumatic transsections/dissections, fistulae, penetrating ulcers]; it is not intended for implantation within the aortic arch. It is typically made of a metal alloy [e.g., nickel-titanium alloy (Nitinol)] that forms an outer mesh structure with an inner synthetic polymer tube (endovascular graft) and is typically designed as a single continuous tube which may be used in singular and/or modular configurations. It is intended for percutaneous introduction; disposable delivery device (e.g., balloon catheter) may be included.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MIH | System, Endovascular Graft, Aortic Aneurysm Treatment |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P110038 | 000 |
P110038 | 001 |
P110038 | 002 |
P110038 | 004 |
P110038 | 005 |
P110038 | 006 |
P110038 | 008 |
P110038 | 009 |
P110038 | 010 |
P110038 | 011 |
P110038 | 012 |
P110038 | 013 |
P110038 | 014 |
P110038 | 015 |
P110038 | 016 |
P110038 | 017 |
P110038 | 018 |
P110038 | 020 |
P110038 | 021 |
P110038 | 022 |
P110038 | 023 |
P110038 | 024 |
P110038 | 025 |
P110038 | 026 |
P110038 | 027 |
P110038 | 029 |
P110038 | 030 |
P110038 | 031 |
P110038 | 032 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 5 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Catheter Gauge: 24 French |
Outer Diameter: 36 Millimeter |
Length: 190 Millimeter |
Outer Diameter: 32 Millimeter |
Device Record Status
6d00a888-1e48-4437-b482-a4d2a8ac2fe5
December 11, 2024
4
February 02, 2021
December 11, 2024
4
February 02, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined