FDA.report

Absolute Pro

Primary DI
08717648176166
Brand
Absolute Pro
Company
ABBOTT VASCULAR INC.
Model
1012536-80
Catalog number
1012536-80
Device description
Absolute Pro Vascular Self-Expanding Stent System 8.0 mm x 80 mm x 135 cm / Over-The-Wire
Published
2014-11-21
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
08717648176166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08717648176166087176481761668717648176166

GMDN Terms

TermDefinition
Iliac artery stent, bare-metalA non-bioabsorbable tubular device intended to be implanted in the common and/or external iliac artery(ies) to maintain arterial patency and luminal diameter in patients with symptomatic atherosclerotic disease. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes the device to expand when inflated, or it may self-expand after insertion with a delivery device. It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. Disposable devices associated with implantation may be included.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius54 Degrees Celsius
Special Storage Condition, Specify00Store at room temperature only.
Storage Environment Temperature-20 Degrees Celsius54 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)227-9902AV.CUSTOMERCARE@AV.ABBOTT.COM

Regulatory Flags

DUNS number
964569052
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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