FDA UDI
In Commercial Distribution
🇺🇸 United States
TREO Abdominal Stent-Graft System
DI: 00843576152106
·
Model: 28-L2-24-100U
·
Bolton Medical Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TREO Abdominal Stent-Graft System
- Primary DI
- 00843576152106
- Version / Model
- 28-L2-24-100U
- Catalog Number
- 28-L2-24-100U
- Company Name
- Bolton Medical Inc.
- Labeler DUNS
- 847424462
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-02
- Public Version
- 8
- Public Version Date
- 2025-09-24
- Public Version Status
- Update
- Public Device Record Key
- b738ae16-4b00-4d68-afea-b122ad8614b8
Device Description
Endovascular Stent-Graft System
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MIH | System, Endovascular Graft, Aortic Aneurysm Treatment | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46777 | Aortoiliac 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 made of a metallic mesh structure with a 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00843576152106 | GS1 |
Premarket Submissions
| 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 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 15 | Millimeter | |
| Outer Diameter | 24 | Millimeter | |
| Length | 103 | Millimeter | |
| Catheter Gauge | 14 | French |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius