FDA.reportPublic FDA data

Pulsar-18 T3

Primary DI
07640130446694
Brand
Pulsar-18 T3
Company
Biotronik AG
Model
7/80/90
Catalog number
430471
Published
2022-07-25
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
07640130446694PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640130446694076401304466947640130446694

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral artery stent, bare-metalA non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, carotid, coronary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion; it might additionally be intended to be implanted in an obstructed biliary duct. The stent is made entirely of metal [e.g., nickel-titanium alloy (Nitinol) mesh structure] and is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded.

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. Short-term temperature excursions between 50 Degr. F and 104 Degr. F allowed
Special Storage Condition, Specify00Keep dry Keep away from sunligth
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature59 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

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Primary DI, Brand, Company table
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