GUDID 20643169014170

INTRDCR 693311 10PK 9F 11CM STDLNE DIALA

MEDTRONIC, INC.

Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable
Primary Device ID20643169014170
NIH Device Record Key1106d495-33b8-4772-867c-934fd56dd290
Commercial Distribution StatusIn Commercial Distribution
Version Model Number693311
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 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

Device Dimensions

Catheter Gauge9 French
Catheter Gauge9 French
Catheter Gauge9 French
Catheter Gauge9 French
Catheter Gauge9 French
Catheter Gauge9 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge9 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge9 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge9 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge9 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge9 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge9 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge9 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge9 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge9 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge9 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge9 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge9 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge9 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge9 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge9 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge9 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge9 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169014176 [Primary]
GS120643169014170 [Package]
Contains: 00643169014176
Package: PK [10 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 Date2016-08-20

Devices Manufactured by MEDTRONIC, INC.

00763000959067 - NA2024-07-02 CUSTOM PACK BB5348R24 PHOEBE P
20763000959818 - NA2024-07-02 CUSTOM PACK BB12G18R1 10PK EXTRA CPG LN
00763000957544 - NA2024-06-28 CUSTOM PACK BB7J30R4 LIV SHUNT
00763000957551 - NA2024-06-28 CUSTOM PACK BBB7S09R13 SUPPRT SM
20763000957760 - NA2024-06-28 CUSTOM PACK BB12G13R 5PK FL MEM MANIFOL
00763000957780 - NA2024-06-28 CUSTOM PACK 11H88R7 ACCESSORY PACK
00763000958015 - NA2024-06-28 CUSTOM PACK HY11R06R2 SUPP 1/4 PK
20763000958033 - NA2024-06-28 CUSTOM PACK BB9B82R2 5PK JUMP PACK

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.