FDA.report

Pulsar-18

Primary DI
07640130436282
Brand
Pulsar-18
Company
Biotronik AG
Model
6/200/90
Catalog number
390691
Published
2017-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
NIPSTENT, SUPERFICIAL FEMORAL ARTERY

Product Code Classifications

CodeDeviceSpecialtyClass
NIPStent, Superficial Femoral ArteryUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640130436282PrimaryGS10

GMDN Terms

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

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

Storage And Handling

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

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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