AccessGUDID - DEVICE: Minima Stent System

GUDID

Device Identifier (DI) Information

Brand Name: Minima Stent System - 6mm
Version or Model: FG-0001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: RENATA MEDICAL, INC.

Primary DI Number: 00196852801862
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 084169964 *Terms of Use

Device Description: Pre-mounted cobalt chromium stent designed for use in the treatment of common congenital and post-operative vascular stenoses.

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?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PNF	Aortic Stent
QWC	Pulmonary Stent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P240003	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4d6e57ec-cb90-4292-ae4b-3127d81bb06b
Public Version Date: April 10, 2025
Public Version Number: 1
DI Record Publish Date: April 02, 2025