FDA.report

PRO-Kinetic Energy

Primary DI
07640130435100
Brand
PRO-Kinetic Energy
Company
Biotronik AG
Model
2.5/20/140
Catalog number
383889
Published
2017-03-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MAFSTENT, CORONARY

Product Code Classifications

CodeDeviceSpecialtyClass
MAFStent, CoronaryUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640130435100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640130435100076401304351007640130435100

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight Keep dry

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888)345-0374jon.brumbaugh@biotronik.com

Regulatory Flags

DUNS number
480862817
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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07640130451575Passeo-35 Xeo3/40/904287862023-02-28
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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

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