FDA.reportPublic FDA data

BioMimics 3D Vascular Stent System

Primary DI
05391526850510
Brand
BioMimics 3D Vascular Stent System
Company
VERYAN MEDICAL LIMITED
Model
144700-12
Catalog number
144700-12
Device description
BioMimics 3D Vascular Stent System 6.0 x 150 mm
Published
2020-08-19
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
P180003000
P180003001
P180003002
P180003003
P180003004
P180003005
P180003006
P180003007
P180003008
P180003009
P180003010
P180003011

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P180003000BioMimics 3D Vascular Stent SystemVeryan Medical, Ltd.2018-10-04NIP
P180003001BioMimics 3D Vascular Stent SystemVeryan Medical, Ltd.2018-10-04NIP
P180003002BioMimics 3D Vascular Stent SystemVeryan Medical, Ltd.2018-10-04NIP
P180003003BioMimics 3D Vascular Stent SystemVeryan Medical, Ltd.2018-10-04NIP
P180003004BioMimics 3D Vascular Stent SystemVeryan Medical, Ltd.2018-10-04NIP
P180003005BioMimics 3D Vascular Stent SystemVeryan Medical, Ltd.2018-10-04NIP
P180003006BioMimics 3D Vascular Stent SystemVeryan Medical, Ltd.2018-10-04NIP
P180003007BioMimics 3D Vascular Stent SystemVeryan Medical, Ltd.2018-10-04NIP
P180003008BioMimics 3D Vascular Stent SystemVeryan Medical, Ltd.2018-10-04NIP
P180003009BioMimics 3D Vascular Stent SystemVeryan Medical, Ltd.2018-10-04NIP
P180003010BioMimics 3D Vascular Stent SystemVeryan Medical, Ltd.2018-10-04NIP
P180003011BioMimics 3D Vascular Stent SystemVeryan Medical, Ltd.2018-10-04NIP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391526850510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391526850510053915268505105391526850510

GMDN Terms#

Term, Definition table
TermDefinition
Multiple peripheral artery stent, bare-metalA sterile non-bioabsorbable tubular device intended to be alternatively implanted in more than one peripheral artery (e.g., iliac, carotid, renal) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease or following the recanalization of a total occlusion. It is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] and may be a continuous tube of a certain length, a mesh structure, or other design for supporting constant blood flow through the artery. Some types may be used in the biliary duct as a secondary intended use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Shaft Length113Centimeter
Stent Diameter6Millimeter
Stent Length150Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Ambient, Dry
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
05391526850725BioMimics 3D Vascular Stent SystemBM3D-06-080-120-UNBM3D-06-080-120-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

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Primary DI, Brand, Company table
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20705032082614S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082652S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
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