Orsiro

Basic Information

• Brand Name: Orsiro
• Primary DI: 07640130439115
• Version / Model: 3.0/22/140
• Catalog Number: 401756
• Company Name: Biotronik AG
• Labeler DUNS: 480862817
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-26
• Public Version: 2
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 358ce420-78b0-4eea-b957-44ee43eafba2

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NIQ	Coronary drug-eluting stent	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
58771	Drug-eluting coronary artery stent, bioabsorbable-polymer-coated	A non-bioabsorbable metal tubular mesh structure covered with a bioabsorbable polymer that contains a drug, 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 is slowly released as the polymer degrades and is intended to inhibit restenosis by reducing vessel smooth muscle cell proliferation. Some types may be dedicated to implantation across a coronary artery bifurcation. Disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640130439115	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Usable Length: 140 cm
Device Size Text, specify			Length: 22 mm
Device Size Text, specify			Diameter: 3 mm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight Store in a dry location
• Type: Storage Environment Temperature
• Temperature Range: High: 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: High: 77 Degrees Fahrenheit