IN.PACT™ AV

GUDID 00763000233150

DCB IAV07008013P 07.00 L080 UL1300 US

MEDTRONIC, INC.

Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated
Primary Device ID00763000233150
NIH Device Record Key22ca0c15-0782-4adf-b9a5-8d9be9e6770d
Commercial Distribution StatusIn Commercial Distribution
Brand NameIN.PACT™ AV
Version Model NumberIAV07008013P
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length80 Millimeter
Outer Diameter7 Millimeter
Length80 Millimeter
Outer Diameter7 Millimeter
Length80 Millimeter
Outer Diameter7 Millimeter
Length80 Millimeter
Outer Diameter7 Millimeter
Length80 Millimeter
Outer Diameter7 Millimeter
Length80 Millimeter
Outer Diameter7 Millimeter
Length80 Millimeter
Outer Diameter7 Millimeter
Length80 Millimeter
Outer Diameter7 Millimeter
Length80 Millimeter
Outer Diameter7 Millimeter
Length80 Millimeter
Outer Diameter7 Millimeter
Length80 Millimeter
Outer Diameter7 Millimeter
Length80 Millimeter
Outer Diameter7 Millimeter
Length80 Millimeter
Outer Diameter7 Millimeter
Length80 Millimeter
Outer Diameter7 Millimeter
Length80 Millimeter
Outer Diameter7 Millimeter
Length80 Millimeter
Outer Diameter7 Millimeter
Length80 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000233150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PRCDrug-coated peripheral transluminal angioplasty catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-16
Device Publish Date2019-12-06

On-Brand Devices [IN.PACT™ AV]

00763000233228DCB IAV10004013P 10.00 L040 UL1300 US
00763000233211DCB IAV09008013P 09.00 L080 UL1300 US
00763000233204DCB IAV09006013P 09.00 L060 UL1300 US
00763000233198DCB IAV09004013P 09.00 L040 UL1300 US
00763000233181DCB IAV08008013P 08.00 L080 UL1300 US
00763000233174DCB IAV08006013P 08.00 L060 UL1300 US
00763000233167DCB IAV08004013P 08.00 L040 UL1300 US
00763000233150DCB IAV07008013P 07.00 L080 UL1300 US
00763000233143DCB IAV07006013P 07.00 L060 UL1300 US
00763000233136DCB IAV07004013P 07.00 L040 UL1300 US
00763000233112DCB IAV06012013P 06.00 L120 UL1300 US
00763000233105DCB IAV06008013P 06.00 L080 UL1300 US
00763000233099DCB IAV06006013P 06.00 L060 UL1300 US
00763000233082DCB IAV06004013P 06.00 L040 UL1300 US
00763000233068DCB IAV05012013P 05.00 L120 UL1300 US
00763000233051DCB IAV05008013P 05.00 L080 UL1300 US
00763000233044DCB IAV05006013P 05.00 L060 UL1300 US
00763000233037DCB IAV05004013P 05.00 L040 UL1300 US
00763000233013DCB IAV04012013P 04.00 L120 UL1300 US
00763000233006DCB IAV04008013P 04.00 L080 UL1300 US
00763000232993DCB IAV04006013P 04.00 L060 UL1300 US
00763000232986DCB IAV04004013P 04.00 L040 UL1300 US
00763000232962DCB IAV10004004P 10.00 L040 UL0400 US
00763000232955DCB IAV09008004P 09.00 L080 UL0400 US
00763000232948DCB IAV09006004P 09.00 L060 UL0400 US
00763000232931DCB IAV09004004P 09.00 L040 UL0400 US
00763000232924DCB IAV08008004P 08.00 L080 UL0400 US
00763000232917DCB IAV08006004P 08.00 L060 UL0400 US
00763000232900DCB IAV08004004P 08.00 L040 UL0400 US
00763000232894DCB IAV07008004P 07.00 L080 UL0400 US
00763000232887DCB IAV07006004P 07.00 L060 UL0400 US
00763000232870DCB IAV07004004P 07.00 L040 UL0400 US
00763000232856DCB IAV06012004P 06.00 L120 UL0400 US
00763000232849DCB IAV06008004P 06.00 L080 UL0400 US
00763000232832DCB IAV06006004P 06.00 L060 UL0400 US
00763000232825DCB IAV06004004P 06.00 L040 UL0400 US
00763000232801DCB IAV05012004P 05.00 L120 UL0400 US
00763000232795DCB IAV05008004P 05.00 L080 UL0400 US
00763000232788DCB IAV05006004P 05.00 L060 UL0400 US
00763000232771DCB IAV05004004P 05.00 L040 UL0400 US
00763000232757DCB IAV04012004P 04.00 L120 UL0400 US
00763000232740DCB IAV04008004P 04.00 L080 UL0400 US
00763000232733DCB IAV04006004P 04.00 L060 UL0400 US
00763000232726DCB IAV04004004P 04.00 L040 UL0400 US
00763000232702DCB IAV10004008P 10.00 L040 UL0800 US
00763000232696DCB IAV09008008P 09.00 L080 UL0800 US
00763000232689DCB IAV09006008P 09.00 L060 UL0800 US
00763000232672DCB IAV09004008P 09.00 L040 UL0800 US
00763000232665DCB IAV08008008P 08.00 L080 UL0800 US
00763000232658DCB IAV08006008P 08.00 L060 UL0800 US

Trademark Results [IN.PACT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IN.PACT
IN.PACT
79320694 not registered Live/Pending
INVATEC Technology Center GmbH
2021-08-10
IN.PACT
IN.PACT
79074790 3864435 Dead/Cancelled
INVATEC Technology Center GmbH
2009-06-19

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