FDA.report

Pulsar-18 T3

Primary DI
07640130446908
Brand
Pulsar-18 T3
Company
Biotronik AG
Model
5/100/135
Catalog number
430492
Published
2022-07-25
Public version status
New
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
NIPSTENT, SUPERFICIAL FEMORAL ARTERY

Product Code Classifications

CodeDeviceSpecialtyClass
NIPStent, Superficial Femoral ArteryUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640130446908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640130446908076401304469087640130446908

GMDN Terms

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

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

Storage And Handling

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

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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