FDA UDI
In Commercial Distribution
🇺🇸 United States
BioMimics 3D Vascular Stent System
DI: 05391526850718
·
Model: BM3D-05-080-120-UN
·
VERYAN MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BioMimics 3D Vascular Stent System
- Primary DI
- 05391526850718
- Version / Model
- BM3D-05-080-120-UN
- Catalog Number
- BM3D-05-080-120-UN
- Company Name
- VERYAN MEDICAL LIMITED
- Labeler DUNS
- 985084616
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-29
- Public Version
- 2
- Public Version Date
- 2026-03-05
- Public Version Status
- Update
- Public Device Record Key
- 9cf1d8d5-b4f1-4a2f-89ba-16d2bb0dd7e3
Device Description
BioMimics 3D Vascular Stent System 5.0 x 80 mm
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 |
|---|---|---|---|---|
| NIP | Stent, Superficial Femoral Artery | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47932 | Peripheral artery stent, bare-metal | A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion. It may additionally be intended to be implanted in an obstructed biliary duct; it is not dedicated to carotid artery implantation, and not intended for connection with an aortic stent. It is made entirely of metal [e.g., Nitinol alloy mesh structure] and typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05391526850718 | GS1 |
Customer Contacts
- Phone
- 8448642001
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P180003 | 012 |
| P180003 | 013 |
| P180003 | 014 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Stent Diameter | 5.0 | Millimeter | |
| Stent Length | 80 | Millimeter | |
| Shaft Length | 120 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry