FDA UDI
In Commercial Distribution
🇺🇸 United States
RelayPro Thoracic Stent-Graft System
DI: 00843576163232
·
Model: 28-M4-44-130-46U
·
Bolton Medical Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RelayPro Thoracic Stent-Graft System
- Primary DI
- 00843576163232
- Version / Model
- 28-M4-44-130-46U
- Catalog Number
- 28-M4-44-130-46U
- Company Name
- Bolton Medical Inc.
- Labeler DUNS
- 847424462
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-03
- Public Version
- 2
- Public Version Date
- 2023-07-04
- Public Version Status
- Update
- Public Device Record Key
- 60f33f0c-f91f-4e6a-ad17-b26c213b3d24
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 |
|---|---|---|---|---|
| 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 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00843576163232 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P200045 | 000 |
| P200045 | 001 |
| P200045 | 002 |
| P200045 | 003 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 44 | Millimeter | |
| Outer Diameter | 46 | Millimeter | |
| Length | 149 | Millimeter | |
| Catheter Gauge | 22 | French |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius