GUDID 00763000343286

BELT 3560019 ENS ISTIM DISP 1PK GLBL MDR

MEDTRONIC, INC.

Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use Personal device holder, single-use
Primary Device ID00763000343286
NIH Device Record Key5d6b59d2-ec41-4bc5-89ad-023bba908bc5
Commercial Distribution StatusIn Commercial Distribution
Version Model Number3560019
Company DUNS796986144
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000343286 [Primary]
GS100763000343286 [Primary]
GS100763000343286 [Primary]
GS100763000343286 [Primary]
GS100763000343286 [Primary]
GS100763000343286 [Primary]
GS100763000343286 [Primary]
GS100763000343286 [Primary]
GS100763000343286 [Primary]
GS100763000343286 [Primary]
GS100763000343286 [Primary]
GS100763000343286 [Primary]
GS100763000343286 [Primary]
GS100763000343286 [Primary]
GS100763000343286 [Primary]
GS100763000343286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZWStimulator, electrical, implantable, for incontinence
EZWStimulator, electrical, implantable, for incontinence
EZWStimulator, electrical, implantable, for incontinence
EZWStimulator, electrical, implantable, for incontinence
EZWStimulator, electrical, implantable, for incontinence
EZWStimulator, electrical, implantable, for incontinence
EZWStimulator, electrical, implantable, for incontinence
EZWStimulator, electrical, implantable, for incontinence
EZWStimulator, electrical, implantable, for incontinence
EZWStimulator, electrical, implantable, for incontinence
EZWStimulator, electrical, implantable, for incontinence
EZWStimulator, electrical, implantable, for incontinence
EZWStimulator, electrical, implantable, for incontinence
EZWStimulator, electrical, implantable, for incontinence
EZWStimulator, electrical, implantable, for incontinence
EZWStimulator, electrical, implantable, for incontinence

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-23
Device Publish Date2021-02-15

Devices Manufactured by MEDTRONIC, INC.

00763000147013 - SELECTSITE™2021-02-26 CATHETER C304-HIS GLOBAL
00763000343286 - NA2021-02-23BELT 3560019 ENS ISTIM DISP 1PK GLBL MDR
00763000343286 - NA2021-02-23 BELT 3560019 ENS ISTIM DISP 1PK GLBL MDR
20763000504643 - NA2021-02-23 CUSTOM PACK BB9P10R2 2PK AV SUPLEM
20763000504667 - NA2021-02-23 CUSTOM PACK BB2U38R3 5PK REPLCMNT
20763000504681 - NA2021-02-23 CUSTOM PACK BB7Z95R2 5PK VENBYPASS
00763000504694 - NA2021-02-23 CUSTOM PACK BB7A98R9 SAVLOOP
20763000504711 - NA2021-02-23 CUSTOM PACK BB4C14R4 4PK BRIDGE
20763000504735 - NA2021-02-23 CUSTOM PACK BB11M35R 5PK OXY PRIMING

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