GUDID 20643169014194

INTRDCR 673323 10PK 7F 23CM PE DILATOR

MEDTRONIC, INC.

Vascular catheter introduction set, nonimplantable
Primary Device ID20643169014194
NIH Device Record Keyc6856dbe-5032-4c2f-9a45-6e475f1a7a1b
Commercial Distribution Discontinuation2018-10-05
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number673323
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

Outer Diameter0.97 Millimeter
Outer Diameter0.97 Millimeter
Outer Diameter0.97 Millimeter
Outer Diameter0.97 Millimeter
Outer Diameter0.97 Millimeter
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge7 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge7 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge7 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge7 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge7 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge7 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge7 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge7 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge7 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge7 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge7 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge7 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge7 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge7 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge7 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge7 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge7 French
Outer Diameter0.97 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169014190 [Primary]
GS120643169014194 [Package]
Contains: 00643169014190
Package: PK [10 Units]
Discontinued: 2018-10-05
Not 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 Number5
Public Version Date2019-06-07
Device Publish Date2016-08-25

Devices Manufactured by MEDTRONIC, INC.

00199150003709 - Sphere-9™ Catheter2026-03-02 CATHETER AFR-00001 SPHERE 9 US GAL
20763000558189 - CLOTtrac™2026-03-02 CONTROL 550-01 CLOTTRAC CWB
20763000558196 - CLOTtrac™2026-03-02 CONTROL 550-07 CLOTTRAC HR 15BX
20763000558202 - CLOTtrac™2026-03-02 CONT 550-08 CLOTTRAC HR ABN BXD ASY
20763000558219 - CLOTtrac™2026-03-02 CONT 550-09 CLOTTRAC LR ABN BXD ASY
20763000558226 - CLOTtrac™2026-03-02 CONT 550-10 CLOTTRAC RACT ABN
20763000558233 - CLOTtrac™2026-03-02 CONTROL 550-12 CLOTTRAC HTC
20763000558295 - RACT2026-03-02 CARTRIDGE 402-02 ACT RACT 17 LAN
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