FDA.reportPublic FDA data

Orsiro

Primary DI
07640130439139
Brand
Orsiro
Company
Biotronik AG
Model
4.0/22/140
Catalog number
401758
Published
2019-02-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NIQCoronary drug-eluting stent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIQCoronary Drug-Eluting StentUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640130439139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640130439139076401304391397640130439139

GMDN Terms#

Term, Definition table
TermDefinition
Drug-eluting coronary artery stent, bioabsorbable-polymer-coatedA sterile 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight Store in a dry location
Storage Environment Temperature025 Degrees Celsius
Storage Environment Temperature077 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)345-0374jon.brumbaugh@biotronik.com
612-423-1738FDA.US.Agent@teleflex.com

Regulatory Flags#

DUNS number
480862817
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640130451490Passeo-35 Xeo4/20/904287782023-02-28
07640130451506Passeo-35 Xeo5/20/904287792023-02-28
07640130451513Passeo-35 Xeo6/20/904287802023-02-28
07640130451520Passeo-35 Xeo7/20/904287812023-02-28
07640130451537Passeo-35 Xeo8/20/904287822023-02-28
07640130451544Passeo-35 Xeo9/20/904287832023-02-28
07640130451551Passeo-35 Xeo10/20/904287842023-02-28
07640130451575Passeo-35 Xeo3/40/904287862023-02-28
07640130451582Passeo-35 Xeo4/40/904287872023-02-28
07640130451599Passeo-35 Xeo5/40/904287882023-02-28
07640130451605Passeo-35 Xeo6/40/904287892023-02-28
07640130451612Passeo-35 Xeo7/40/904287902023-02-28
07640130451629Passeo-35 Xeo8/40/904287912023-02-28
07640130451636Passeo-35 Xeo9/40/904287922023-02-28
07640130451643Passeo-35 Xeo10/40/904287932023-02-28
07640130451650Passeo-35 Xeo12/40/904287942023-02-28
07640130451667Passeo-35 Xeo3/60/904287952023-02-28
07640130451674Passeo-35 Xeo4/60/904287962023-02-28
07640130451681Passeo-35 Xeo5/60/904287972023-02-28
07640130451698Passeo-35 Xeo6/60/904287982023-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290107017930EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107017947EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107017954EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107017961EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107017978EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107017985EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107017992EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107018005EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
08717648231261XIENCE Skypoint™ABBOTT VASCULAR INC.NIQ2023-12-15
08717648231278XIENCE Skypoint™ABBOTT VASCULAR INC.NIQ2023-12-15
08717648231285XIENCE Skypoint™ABBOTT VASCULAR INC.NIQ2023-12-15
08717648231308XIENCE Skypoint™ABBOTT VASCULAR INC.NIQ2023-12-15
08717648231315XIENCE Skypoint™ABBOTT VASCULAR INC.NIQ2023-12-15
07290107015202EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015219EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015226EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015233EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015240EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015257EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015264EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015271EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015288EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015295EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015301EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015318EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015325EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015332EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015349EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015356EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015363EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10