Omnilink Elite 1012633-29

GUDID 08717648178580

Omnilink Elite Vascular Balloon-Expandable Stent System 10.0 mm x 29 mm x 135 cm Over-The-Wire

ABBOTT VASCULAR INC.

Iliac artery stent, bare-metal
Primary Device ID08717648178580
NIH Device Record Keye7078b4b-b10f-43a1-bd82-08d9d8c105f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmnilink Elite
Version Model Number1012633-29
Catalog Number1012633-29
Company DUNS964569052
Company NameABBOTT VASCULAR INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, keep away from sunlight, temperature limitation 15 to 30 degrees C (59 F to 86 degrees F)
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108717648178580 [Primary]

FDA Product Code

NIOSTENT, ILIAC

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-02-05
Device Publish Date2014-11-21

On-Brand Devices [Omnilink Elite]

08717648179563Omnilink Elite Vascular Balloon-Expandable Stent System 7.0 mm x 16 mm x 135 cm Over-The-Wire
08717648179556Omnilink Elite Vascular Balloon-Expandable Stent System 7.0 mm x 12 mm x 135 cm Over-The-Wire
08717648179549Omnilink Elite Vascular Balloon-Expandable Stent System 6.0 mm x 59 mm x 135 cm Over-The-Wire
08717648179532Omnilink Elite Vascular Balloon-Expandable Stent System 6.0 mm x 39 mm x 135 cm Over-The-Wire
08717648179525Omnilink Elite Vascular Balloon-Expandable Stent System 6.0 mm x 29 mm x 135 cm Over-The-Wire
08717648179518Omnilink Elite Vascular Balloon-Expandable Stent System 6.0 mm x 19 mm x 135 cm Over-The-Wire
08717648179501Omnilink Elite Vascular Balloon-Expandable Stent System 6.0 mm x 16 mm x 135 cm Over-The-Wire
08717648179495Omnilink Elite Vascular Balloon-Expandable Stent System 6.0 mm x 12 mm x 135 cm Over-The-Wire
08717648179396Omnilink Elite Vascular Balloon-Expandable Stent System 10.0 mm x 59 mm x 80 cm Over-The-Wire
08717648179389Omnilink Elite Vascular Balloon-Expandable Stent System 10.0 mm x 39 mm x 80 cm Over-The-Wire
08717648179372Omnilink Elite Vascular Balloon-Expandable Stent System 10.0 mm x 29 mm x 80 cm Over-The-Wire
08717648179365Omnilink Elite Vascular Balloon-Expandable Stent System 10.0 mm x19 mm x 80 cm Over-The-Wire
08717648179358Omnilink Elite Vascular Balloon-Expandable Stent System 9.0 mm x 59 mm x 80 cm Over-The-Wire
08717648179341Omnilink Elite Vascular Balloon-Expandable Stent System 9.0 mm x 39 mm x 80 cm Over-The-Wire
08717648179334Omnilink Elite Vascular Balloon-Expandable Stent System 9.0 mm x 29 mm x 80 cm Over-The-Wire
08717648179327Omnilink Elite Vascular Balloon-Expandable Stent System 9.0 mm x 19 mm x 80 cm Over-The-Wire
08717648179310Omnilink Elite Vascular Balloon-Expandable Stent System 8.0 mm x 59 mm x 80 cm Over-The-Wire
08717648179303Omnilink Elite Vascular Balloon-Expandable Stent System 8.0 mm x 39 mm x 80 cm Over-The-Wire
08717648179297Omnilink Elite Vascular Balloon-Expandable Stent System 8.0 mm x 29 mm x 80 cm Over-The-Wire
08717648179280Omnilink Elite Vascular Balloon-Expandable Stent System 8.0 mm x 19 mm x 80 cm Over-The-Wire
08717648179273Omnilink Elite Vascular Balloon-Expandable Stent System 7.0 mm x 59 mm x 80cm Over-The-Wire
08717648179266Omnilink Elite Vascular Balloon-Expandable Stent System 7.0 mm x 39 mm x 80 cm Over-The-Wire
08717648179259Omnilink Elite Vascular Balloon-Expandable Stent System 7.0 mm x 29 mm x 80 cm Over-The-Wire
08717648179242Omnilink Elite Vascular Balloon-Expandable Stent System 7.0 mm x 19 mm x 80 cm Over-The-Wire
08717648179235Omnilink Elite Vascular Balloon-Expandable Stent System 7.0 mm x 16 mm x 80 cm Over-The-Wire
08717648179228Omnilink Elite Vascular Balloon-Expandable Stent System 7.0 mm x 12 mm x 80 cm Over-The-Wire
08717648179211Omnilink Elite Vascular Balloon-Expandable Stent System 6.0 mm x 59 mm x 80 cm Over-The-Wire
08717648179204Omnilink Elite Vascular Balloon-Expandable Stent System 6.0 mm x 39 mm x 80 cm Over-The-Wire
08717648179198Omnilink Elite Vascular Balloon-Expandable Stent System 6.0 mm x 29 mm x 80 cm Over-The-Wire
08717648179181Omnilink Elite Vascular Balloon-Expandable Stent System 6.0 mm x 19 mm x 80 cm Over-The-Wire
08717648179174Omnilink Elite Vascular Balloon-Expandable Stent System 6.0 mm x 16 mm x 80 cm Over-The-Wire
08717648179167Omnilink Elite Vascular Balloon-Expandable Stent System 6.0 mm x 12 mm x 80 cm Over-The-Wire
08717648178603Omnilink Elite Vascular Balloon-Expandable Stent System 10.0 mm x 59 mm x 135 cm Over-The-Wire
08717648178597Omnilink Elite Vascular Balloon-Expandable Stent System 10.0 mm x 39 mm x 135 cm Over-The-Wire
08717648178580Omnilink Elite Vascular Balloon-Expandable Stent System 10.0 mm x 29 mm x 135 cm Over-The-Wire
08717648178573Omnilink Elite Vascular Balloon-Expandable Stent System 10.0 mm x 19 mm x 135 cm Over-The-Wire
08717648178566Omnilink Elite Vascular Balloon-Expandable Stent System 9.0 mm x 59 mm x 135 cm Over-The-Wire
08717648178559Omnilink Elite Vascular Balloon-Expandable Stent System 9.0 mm x 39 mm x 135 cm Over-The-Wire
08717648178542Omnilink Elite Vascular Balloon-Expandable Stent System 9.0 mm x 29 mm x 135 cm Over-The-Wire
08717648178535Omnilink Elite Vascular Balloon-Expandable Stent System 9.0 mm x 19 mm x 135 cm Over-The-Wire
08717648178528Omnilink Elite Vascular Balloon-Expandable Stent System 8.0 mm x 59 mm x 135 cm Over-The-Wire
08717648178511Omnilink Elite Vascular Balloon-Expandable Stent System 8.0 mm x 39 mm x 135 cm Over-The-Wire
08717648178504Omnilink Elite Vascular Balloon-Expandable Stent System 8.0 mm x 29 mm x 135 cm Over-The-Wire
08717648178498Omnilink Elite Vascular Balloon-Expandable Stent System 8.0 mm x 19 mm x 135 cm Over-The-Wire
08717648178481Omnilink Elite Vascular Balloon-Expandable Stent System 7.0 mm x 59 mm x 135 cm Over-The-Wire
08717648178474Omnilink Elite Vascular Balloon-Expandable Stent System 7.0 mm x 39 mm x 135 cm Over-The-Wire
08717648178467Omnilink Elite Vascular Balloon-Expandable Stent System 7.0 mm x 29 mm x 135 cm Over-The-Wire
08717648178450Omnilink Elite Vascular Balloon-Expandable Stent System 7.0 mm x 19 mm x 135 cm Over-The-Wire

Trademark Results [Omnilink Elite]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OMNILINK ELITE
OMNILINK ELITE
77335058 3737520 Live/Registered
Abbott Cardiovascular Systems Inc.
2007-11-21

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