AccessGUDID - DEVICE: EluNIR-PERL Ridaforolimus Eluting Coronary Stent System (07290107015615)

GUDID

Device Identifier (DI) Information

Brand Name: EluNIR-PERL Ridaforolimus Eluting Coronary Stent System
Version or Model: ELM400R28US
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDINOL LTD.

Primary DI Number: 07290107015615
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600593800 *Terms of Use

Device Description: No description.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
56284	Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated	A non-bioabsorbable metal tubular mesh structure covered with a non-bioabsorbable polymer and a drug coating that is designed to be implanted, via a delivery catheter, into a coronary artery (or saphenous vein graft) to maintain its patency typically in a patient with symptomatic atherosclerotic heart disease. The drug coating is slowly released and intended to inhibit restenosis by reducing vessel smooth muscle cell proliferation. Disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NIQ	Coronary Drug-Eluting Stent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P170008	037

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: Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F)

Clinically Relevant Size

[?]

Size Type Text
Length: 28 Millimeter
Lumen/Inner Diameter: 4.0 Millimeter

Device Record Status

Public Device Record Key: 00d11f0f-f45a-4868-ae0a-f06bbbf4d120
Public Version Date: December 18, 2023
Public Version Number: 1
DI Record Publish Date: December 10, 2023