GUDID 00613994501011

SERVICE KIT 5873C INTL US

MEDTRONIC, INC.

Pacing/defibrillation lead repair kit Pacing/defibrillation lead repair kit
Primary Device ID00613994501011
NIH Device Record Key64d0d2cd-fd79-4ac4-894c-432392cb2403
Commercial Distribution StatusIn Commercial Distribution
Version Model Number5873C
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

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994501011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXYimplantable pacemaker Pulse-generator

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 Date2014-09-23

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