GUDID 20613994885887

WIRE 004455 100PK BNS .038X145 3MMJ PTFE

MEDTRONIC, INC.

Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use
Primary Device ID20613994885887
NIH Device Record Keyd8752258-8619-4a1b-b94a-2e94f5adc031
Commercial Distribution Discontinuation2017-08-02
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number004455
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count100
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place. Do not expose to organic solvents.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dark, dry place. Do not expose to organic solvents.

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994885883 [Unit of Use]
GS120613994885887 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQXWIRE, GUIDE, CATHETER

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

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

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