AccessGUDID - DEVICE: BioMimics 3D Vascular Stent System (05391526850428)

GUDID

Device Identifier (DI) Information

Brand Name: BioMimics 3D Vascular Stent System
Version or Model: 142122-06
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 142122-06
Company Name: VERYAN MEDICAL LIMITED

Primary DI Number: 05391526850428
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 985084616 *Terms of Use

Device Description: BioMimics 3D Vascular Stent System 6.0 x 80 mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NIP	Stent, Superficial Femoral Artery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P180003	000
P180003	001
P180003	002
P180003	003
P180003	004
P180003	005
P180003	006
P180003	007
P180003	008
P180003	009
P180003	010
P180003	011

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
Stent Diameter: 6.0 Millimeter
Stent Length: 80 Millimeter
Shaft Length: 113 Centimeter

Device Record Status

Public Device Record Key: a4876862-1cfc-4209-842c-f652a7d3aadb
Public Version Date: December 11, 2024
Public Version Number: 12
DI Record Publish Date: August 19, 2020