FDA.report

Astron

Primary DI
07640130412293
Brand
Astron
Company
Biotronik AG
Model
9/40/72
Catalog number
364654
Published
2016-01-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NIOSTENT, ILIAC

Product Code Classifications

CodeDeviceSpecialtyClass
NIOStent, IliacUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640130412293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640130412293076401304122937640130412293

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