GUDID 20643169014217

INTRDCR 663311 10PK 6F PE DILATOR 11CM

MEDTRONIC, INC.

Vascular catheter introduction set, nonimplantable
Primary Device ID20643169014217
NIH Device Record Keyba0e4223-02c0-43ce-b465-1c7669ea1c8f
Commercial Distribution StatusIn Commercial Distribution
Version Model Number663311
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 Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge6 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge6 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge6 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge6 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge6 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge6 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge6 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge6 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge6 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge6 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge6 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge6 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge6 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge6 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge6 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge6 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge6 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169014213 [Primary]
GS120643169014217 [Package]
Contains: 00643169014213
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 Date2017-02-02

Devices Manufactured by MEDTRONIC, INC.

00199150031610 - NA2025-07-21 CUSTOM PACK BB1U06R24 CHRIS AD
00199150032464 - NA2025-07-21 CUSTOM PACK BB10R35R4 CP PRIME
20199150032482 - NA2025-07-21 CUSTOM PACK 6S19R4 10PK DIALYSIS
00199150033423 - NA2025-07-21 CUSTOM PACK BB12B90R7 SPECTRU
20199150033571 - NA2025-07-21 CUSTOM PACK BB2U59R3 2PK 1/4 TBL L
00199150033614 - NA2025-07-21 CUSTOM PACK BB10J74R14 3/8CNTRIS
00199150034246 - NA2025-07-21 CUSTOM PACK BB11J86R12 ADULT E
00763000925093 - FlexCath Cross™ Transseptal Solution2025-07-21 NDL 900302 FLEXCATH CROSS SL 63CM EIFU

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.