FDA.reportPublic FDA data

Pulsar-18

Primary DI
07640130436442
Brand
Pulsar-18
Company
Biotronik AG
Model
4/100/135
Catalog number
390707
Published
2017-04-12
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
NIPSTENT, SUPERFICIAL FEMORAL ARTERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIPStent, Superficial Femoral ArteryUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640130436442PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640130436442076401304364427640130436442

GMDN Terms#

Term, Definition table
TermDefinition
Multiple peripheral artery stent, bare-metalA sterile non-bioabsorbable tubular device intended to be alternatively implanted in more than one peripheral artery (e.g., iliac, carotid, renal) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease or following the recanalization of a total occlusion. It is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] and may be a continuous tube of a certain length, a mesh structure, or other design for supporting constant blood flow through the artery. Some types may be used in the biliary duct as a secondary intended use.

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
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Handling Environment Temperature50 Degrees Fahrenheit86 Degrees Fahrenheit
Special Storage Condition, Specify00Keep away from sunlight store in a dry location

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

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Primary DI, Brand, Company table
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