FDA.reportPublic FDA data

BioMimics 3D Vascular Stent System

Primary DI
05391526850725
Brand
BioMimics 3D Vascular Stent System
Company
VERYAN MEDICAL LIMITED
Model
BM3D-06-080-120-UN
Catalog number
BM3D-06-080-120-UN
Device description
BioMimics 3D Vascular Stent System 6.0 x 80 mm
Published
2025-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NIPStent, Superficial Femoral Artery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIPStent, Superficial Femoral ArteryUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P180003012
P180003013
P180003014

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P180003012BioMimics 3D Vascular Stent SystemVeryan Medical, Ltd.2018-10-04NIP
P180003013BioMimics 3D Vascular Stent SystemVeryan Medical, Ltd.2018-10-04NIP
P180003014BioMimics 3D Vascular Stent SystemVeryan Medical, Ltd.2018-10-04NIP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391526850725PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391526850725053915268507255391526850725

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral artery stent, bare-metalA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Shaft Length120Centimeter
Stent Diameter6Millimeter
Stent Length80Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8448642001customersupportUS@veryamed.com

Regulatory Flags#

DUNS number
985084616
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391526850688BioMimics 3D Vascular Stent SystemBM3D-05-060-120-UNBM3D-05-060-120-UN2025-08-29
05391526850695BioMimics 3D Vascular Stent SystemBM3D-06-060-120-UNBM3D-06-060-120-UN2025-08-29
05391526850701BioMimics 3D Vascular Stent SystemBM3D-07-060-120-UNBM3D-07-060-120-UN2025-08-29
05391526850718BioMimics 3D Vascular Stent SystemBM3D-05-080-120-UNBM3D-05-080-120-UN2025-08-29
05391526850732BioMimics 3D Vascular Stent SystemBM3D-07-080-120-UNBM3D-07-080-120-UN2025-08-29
05391526850749BioMimics 3D Vascular Stent SystemBM3D-05-100-120-UNBM3D-05-100-120-UN2025-08-29
05391526850756BioMimics 3D Vascular Stent SystemBM3D-06-100-120-UNBM3D-06-100-120-UN2025-08-29
05391526850763BioMimics 3D Vascular Stent SystemBM3D-07-100-120-UNBM3D-07-100-120-UN2025-08-29
05391526850770BioMimics 3D Vascular Stent SystemBM3D-05-125-120-UNBM3D-05-125-120-UN2025-08-29
05391526850787BioMimics 3D Vascular Stent SystemBM3D-06-125-120-UNBM3D-06-125-120-UN2025-08-29
05391526850794BioMimics 3D Vascular Stent SystemBM3D-07-125-120-UNBM3D-07-125-120-UN2025-08-29
05391526850800BioMimics 3D Vascular Stent SystemBM3D-05-150-120-UNBM3D-05-150-120-UN2025-08-29
05391526850817BioMimics 3D Vascular Stent SystemBM3D-06-150-120-UNBM3D-06-150-120-UN2025-08-29
05391526850824BioMimics 3D Vascular Stent SystemBM3D-07-150-120-UNBM3D-07-150-120-UN2025-08-29
05391526850381BioMimics 3D Vascular Stent System142122-01142122-012020-08-19
05391526850398BioMimics 3D Vascular Stent System142122-02142122-022020-08-19
05391526850404BioMimics 3D Vascular Stent System142122-03142122-032020-08-19
05391526850411BioMimics 3D Vascular Stent System142122-05142122-052020-08-19
05391526850428BioMimics 3D Vascular Stent System142122-06142122-062020-08-19
05391526850435BioMimics 3D Vascular Stent System142122-07142122-072020-08-19

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