GUDID 20643169469925

WIRE ANGIO 948901 .032 X260CM 3MMJ PTFE

MEDTRONIC, INC.

Cardiac/peripheral vascular guidewire, single-use
Primary Device ID20643169469925
NIH Device Record Key318d49d3-b827-407e-9747-074b026e0475
Commercial Distribution StatusIn Commercial Distribution
Version Model Number948901
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

Device Dimensions

Length260 Centimeter
Length260 Centimeter
Length260 Centimeter
Length260 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169469921 [Primary]
GS120643169469925 [Package]
Contains: 00643169469921
Package: PK [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQXWIRE, GUIDE, CATHETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-11

Devices Manufactured by MEDTRONIC, INC.

00199150007172 - NA2025-04-21 CUSTOM PACK PDBB11V44R10 CORE PIX
00199150007547 - NA2025-04-21 CUSTOM PACK SSBB10Z49R20 NEW CONFIG
00763000812041 - NA2025-04-21 CAP 5867-3M STERILE MDR
00763000812058 - NA2025-04-21 SERVICE KIT 5873C LEAD MDR
00763000947064 - Bio-Medicus™2025-04-21 CANNULA 96530-115 BIO-MEDICUS 15FR
00763000947071 - Bio-Medicus™2025-04-21 CANNULA 96530-117 BIO-MEDICUS 17FR
00763000947088 - Bio-Medicus™2025-04-21 CANNULA 96530-119 BIO-MEDICUS 19FR
00763000947095 - Bio-Medicus™2025-04-21 CANNULA 96530-121 BIO-MEDICUS 21FR

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