Model: M-A-ES-1022
DI: 07290116280998
Status: New
MRI: MR Conditional
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-10
Current Version: 2026-05-18
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2c70e51c-0efe-4c03-96cf-8e7d728f9417
Distribution Status:
In Commercial Distribution
DUNS Number:
532700825
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
07290116280998
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 62573
Name: Aortic arch endovascular stent-graft
Definition:
A non-bioabsorbable tubular device intended for endovascular implantation, in a modular configuration, to repair lesions of the aortic arch and descending thoracic aorta. 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). It includes a docking portal(s) for attachment of an ancillary endovascular stent-graft(s) [not included] to occupy and allow flow to an aortic arch branch vessel(s). It is percutaneously inserted via the femoral artery to the site of implantation and expanded in situ; disposable devices associated with implantation may be included.
FDA Product Codes
SDZ
Endovascular System For Treatment Of Ascending Aorta And Aortic Arch Lesions
Premarket Submissions
Submission Number:
P250033
Supplement Number:
000