FDA UDI
In Commercial Distribution
🇺🇸 United States
Minima Stent System - 6mm
DI: 00196852801862
·
Model: FG-0001
·
RENATA MEDICAL, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Minima Stent System - 6mm
- Primary DI
- 00196852801862
- Version / Model
- FG-0001
- Company Name
- RENATA MEDICAL, INC.
- Labeler DUNS
- 084169964
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-02
- Public Version
- 1
- Public Version Date
- 2025-04-10
- Public Version Status
- New
- Public Device Record Key
- 4d6e57ec-cb90-4292-ae4b-3127d81bb06b
Device Description
Pre-mounted cobalt chromium stent designed for use in the treatment of common congenital and post-operative vascular stenoses.
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 |
|---|---|---|---|---|
| PNF | Aortic Stent | Unknown | 3 | |
| QWC | Pulmonary Stent | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43521 | Bare-metal aortic stent | A non-bioabsorbable tubular device intended to be implanted in the aorta to maintain aortic patency and improve luminal diameter in patients with symptomatic atherosclerotic disease or recurrent coarctation (narrowing) of the aorta. It is made of metal (e.g., platinum/iridium wire with gold braze) and may be inserted with a balloon catheter which when inflated causes the device to expand, or the device may self-expand after being delivered to the site of implantation. The device is typically a mesh structure in tubular form; it is available in a variety of lengths and diameters. Disposable devices associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00196852801862 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P240003 | 000 |