GUDID 00613994752178

ACC 3625 SCREENER BEI REDESIGN US MKT

MEDTRONIC, INC.

Implantable incontinence-control electrical stimulation system
Primary Device ID00613994752178
NIH Device Record Key82a9cffc-dbc8-4287-ba05-5ba93c5a173b
Commercial Distribution StatusIn Commercial Distribution
Version Model Number3625
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 Usefalse
Lot Batchfalse
Serial Numbertrue
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 Identifiers

Device Issuing AgencyDevice ID
GS100613994752178 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRUimplanted subcortical electrical Stimulator (motor disorders)

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 Date2014-09-23

Devices Manufactured by MEDTRONIC, INC.

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