FDA.reportPublic FDA data

PK Papyrus

Primary DI
07640130447271
Brand
PK Papyrus
Company
Biotronik AG
Model
3.0/26/140
Catalog number
434899
Published
2019-04-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NIVcoronary covered stent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIVCoronary Covered StentUnknownf

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640130447271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640130447271076401304472717640130447271

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal coronary artery stentA non-bioabsorbable tubular device [bare metal stent (BMS)] intended to be implanted in a coronary artery or saphenous vein graft of the heart to maintain luminal patency and improve luminal diameter typically in a patient with symptomatic atherosclerotic heart disease. It is typically made of high-grade stainless steel or cobalt-chrome (Co-Cr), may be linear or have a bifurcation design (e.g., shaped as a Y in a tube form), and may be balloon-expanded or self-expandable. Dedicated disposable implantation devices (e.g., balloon catheter, delivery instrument) 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
Special Storage Condition, Specify00Keep dry Keep away from sunlight
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit77 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
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
07640130447158PK PapyrusBiotronik AGNIV2019-04-08
07640130447165PK PapyrusBiotronik AGNIV2019-04-08
07640130447172PK PapyrusBiotronik AGNIV2019-04-08
07640130447189PK PapyrusBiotronik AGNIV2019-04-08
07640130447196PK PapyrusBiotronik AGNIV2019-04-08
07640130447202PK PapyrusBiotronik AGNIV2019-04-08
07640130447219PK PapyrusBiotronik AGNIV2019-04-08
07640130447226PK PapyrusBiotronik AGNIV2019-04-08
07640130447233PK PapyrusBiotronik AGNIV2019-04-08
07640130447240PK PapyrusBiotronik AGNIV2019-04-08
07640130447257PK PapyrusBiotronik AGNIV2019-04-08
07640130447264PK PapyrusBiotronik AGNIV2019-04-08
07640130447288PK PapyrusBiotronik AGNIV2019-04-08
07640130447295PK PapyrusBiotronik AGNIV2019-04-08
07640130447301PK PapyrusBiotronik AGNIV2019-04-08
07640130447318PK PapyrusBiotronik AGNIV2019-04-08
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08717648176463GraftmasterABBOTT VASCULAR INC.NIV2014-11-21
08717648176470GraftmasterABBOTT VASCULAR INC.NIV2014-11-21
08717648176487GraftmasterABBOTT VASCULAR INC.NIV2014-11-21
08717648176494GraftmasterABBOTT VASCULAR INC.NIV2014-11-21
08717648176500GraftmasterABBOTT VASCULAR INC.NIV2014-11-21
08717648176517GraftmasterABBOTT VASCULAR INC.NIV2014-11-21