GUDID 20643169014194

INTRDCR 673323 10PK 7F 23CM PE DILATOR

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 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.

00763000902537 - Launcher™2024-06-04 CATHETER LA83DRCD LA 8F 90CM 3DRC
00763000902544 - Launcher™2024-06-04 CATHETER LA83DRCSH LA 8F 100CM 3DRC
00763000902551 - Launcher™2024-06-04 CATHETER LA83DRCSHD LA 8F 90CM 3DRC
00763000902568 - Launcher™2024-06-04 CATHETER LA83DRIGHT LA 8F 100CM 3DRGT
00763000902575 - Launcher™2024-06-04 CATHETER LA83DRIGHTD LA 8F 90CM 3DRGT
00763000902582 - Launcher™2024-06-04 CATHETER LA8AL10 LA 8F 100CM AL10
00763000902599 - Launcher™2024-06-04 CATHETER LA8AL10D LA 8F 90CM AL10
00763000902605 - Launcher™2024-06-04 CATHETER LA8AL10F LA 8F 80CM AL10

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