In.Pact™ 018

GUDID 00763000291167

DCB 018 IPU04004020P D4.0 L040 UL0200

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
Primary Device ID00763000291167
NIH Device Record Keybc5707ef-3adb-4c4b-b284-cd9c04a42bd0
Commercial Distribution StatusIn Commercial Distribution
Brand NameIn.Pact™ 018
Version Model NumberIPU04004020P
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 Perscriptiontrue
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

Device Dimensions

Length40 Millimeter
Outer Diameter4 Millimeter
Length40 Millimeter
Outer Diameter4 Millimeter
Length40 Millimeter
Outer Diameter4 Millimeter
Length40 Millimeter
Outer Diameter4 Millimeter
Length40 Millimeter
Outer Diameter4 Millimeter
Length40 Millimeter
Outer Diameter4 Millimeter
Length40 Millimeter
Outer Diameter4 Millimeter
Length40 Millimeter
Outer Diameter4 Millimeter

Operating and Storage Conditions

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 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources.
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 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources.
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 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources.
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 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources.
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 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources.
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 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources.
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 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources.
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 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the original container. Do not store near radiation or ultraviolet light sources.

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000291167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ONUDrug-Eluting 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 Date2022-06-27
Device Publish Date2022-06-18

On-Brand Devices [In.Pact™ 018]

00763000291679DCB 018 IPU06015020P D6.0 L150 UL0200
00763000291662DCB 018 IPU06015013P D6.0 L150 UL0130
00763000291648DCB 018 IPU06012020P D6.0 L120 UL0200
00763000291631DCB 018 IPU06012013P D6.0 L120 UL0130
00763000291617DCB 018 IPU06010020P D6.0 L100 UL0200
00763000291600DCB 018 IPU06010013P D6.0 L100 UL0130
00763000291587DCB 018 IPU06008020P D6.0 L080 UL0200
00763000291570DCB 018 IPU06008013P D6.0 L080 UL0130
00763000291556DCB 018 IPU06006020P D6.0 L060 UL0200
00763000291549DCB 018 IPU06006013P D6.0 L060 UL0130
00763000291525DCB 018 IPU06004020P D6.0 L040 UL0200
00763000291518DCB 018 IPU06004013P D6.0 L040 UL0130
00763000291495DCB 018 IPU05015020P D5.0 L150 UL0200
00763000291488DCB 018 IPU05015013P D5.0 L150 UL0130
00763000291464DCB 018 IPU05012020P D5.0 L120 UL0200
00763000291457DCB 018 IPU05012013P D5.0 L120 UL0130
00763000291433DCB 018 IPU05010020P D5.0 L100 UL0200
00763000291426DCB 018 IPU05010013P D5.0 L100 UL0130
00763000291402DCB 018 IPU05008020P D5.0 L080 UL0200
00763000291396DCB 018 IPU05008013P D5.0 L080 UL0130
00763000291372DCB 018 IPU05006020P D5.0 L060 UL0200
00763000291365DCB 018 IPU05006013P D5.0 L060 UL0130
00763000291341DCB 018 IPU05004020P D5.0 L040 UL0200
00763000291334DCB 018 IPU05004013P D5.0 L040 UL0130
00763000291310DCB 018 IPU04015020P D4.0 L150 UL0200
00763000291303DCB 018 IPU04015013P D4.0 L150 UL0130
00763000291280DCB 018 IPU04012020P D4.0 L120 UL0200
00763000291273DCB 018 IPU04012013P D4.0 L120 UL0130
00763000291259DCB 018 IPU04010020P D4.0 L100 UL0200
00763000291242DCB 018 IPU04010013P D4.0 L100 UL0130
00763000291228DCB 018 IPU04008020P D4.0 L080 UL0200
00763000291211DCB 018 IPU04008013P D4.0 L080 UL0130
00763000291198DCB 018 IPU04006020P D4.0 L060 UL0200
00763000291181DCB 018 IPU04006013P D4.0 L060 UL0130
00763000291167DCB 018 IPU04004020P D4.0 L040 UL0200
00763000291150DCB 018 IPU04004013P D4.0 L040 UL0130
00763000291761DCB 018 IPU07008020P D7.0 L080 UL0200
00763000291754DCB 018 IPU07008013P D7.0 L080 UL0130
00763000291730DCB 018 IPU07006020P D7.0 L060 UL0200
00763000291723DCB 018 IPU07006013P D7.0 L060 UL0130
00763000291709DCB 018 IPU07004020P D7.0 L040 UL0200
00763000291693DCB 018 IPU07004013P D7.0 L040 UL0130

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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