SOLO-TRAK®-KR

GUDID 10681490143094

INTRODUCER 6208BTK5 LEAD BRAIDED 5PK

MEDTRONIC, INC.

Vascular catheter introduction set, nonimplantable
Primary Device ID10681490143094
NIH Device Record Key608d7e6f-3de9-4f6f-bd30-e17f6d2e076e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOLO-TRAK®-KR
Version Model Number6208BTK5
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 Kittrue
Device Combination Productfalse
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
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
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

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Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100681490143097 [Primary]
GS110681490143094 [Package]
Contains: 00681490143097
Package: PK [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBINTRODUCER, CATHETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-07
Device Publish Date2017-01-03

On-Brand Devices [SOLO-TRAK®-KR]

10681490143735INTRO 6212BTK-5 5PK 12FR
10681490143599INTRO 6211BTK5 5PK BRAIDED
00681490143585INTRO 6211BTK-1 1PK INTRODUCER 11FR 10L
00681490143448INTRO 6210BTKL1 KINK RESIST X-LONG 10L
00681490143431ACCESS 6210BTK-D1 INTRODUCER 10F
10681490143421INTRO 6210BTK-5 5PK 10FR 10L
00681490143417INTRO 6210BTK-1 1PK INTRODUCER 10FR 10L
00681490143288INTRO 6209BTKL1 KINK RESISTEX LONG 10L
00681490143271INTRO 6209BTK-D1 INTROD 9FR DUAL CH 10L
10681490143261INTRO 6209BTK-5 5PK 9FR 10L
00681490143257INTRO 6209BTK-1 1PK INTRODUCER 9FR 10L
00681490143110LEAD 6208BTKL1 INTRO-KINK RES EX LG 10L
00681490143103INTRO 6208BTK-D1 INTROD 8FR DUAL CH 10L
10681490143094INTRODUCER 6208BTK5 LEAD BRAIDED 5PK
00681490143080INTRO 6208BTK-1 1PK INTRODUCER 8FR 10L
00681490142960PLI 6207BTKL1 SOLOTRAK KINK RESIS EX LNG
00681490142953INTRO 6207BTK-D1 7FR DC 10L
10681490142943INTRO 6207BTK-5 5PK J5 7 FR
00681490142939INTRO 6207BTK-1 7FR SINGLE 10L
00721902577451PLI 6210BTKL1S SOLOTRAK XLG W/SN 10.5FR
00721902577437INTRODUCER 6209BTKL1S LEAD SGL PK SGL CH
00721902577413INTRODUCER 6208BTKL1S LEAD SGL PK SGL CH
00721902577406PLI 6207BTKL1S SOLTRAK X LG W/SN 7FR
10721902577304PLI 6210BTK5S SOLOTRAK W/SN 10.5FR 5PK
10721902577281PLI 6209BTK5S SOLOTRAK W/SN 9FR
10721902577274PLI 6208BTK5S SOLOTRAK W/SN 8FR
10721902577267PLI 6207BTK5S SOLOTRAK W/SN 7FR
00721902577192PLI 6209BTK1S SOLOTRAK W/SN 9FR
00721902577178PLI 6208BTK1S SOLOTRAK W/SN 8FR
00721902577161PLI 6207BTK1S SOLOTRAK W/SN 7FR

Trademark Results [SOLO-TRAK]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOLO-TRAK
SOLO-TRAK
74176693 1763650 Live/Registered
Medtronic, Inc.
1991-06-17

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