GUDID 00613994729989

ACC 355018 INTRODUCER KIT INTERSTIM US

MEDTRONIC, INC.

Neurosurgical procedure kit, non-medicated, single-use
Primary Device ID00613994729989
NIH Device Record Key5fbc6212-98e4-4b07-8d59-d0fb345c30e8
Commercial Distribution StatusIn Commercial Distribution
Version Model Number355018
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
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
GS100613994729989 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZBSTIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

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 Date2015-06-08

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00763000911089 - NA2025-03-03 FOOT SWITCH NITRONFS GLOBAL
20763000954363 - N/A2025-03-03 PATCH AFR-00007 LOCATION REF 4PK US
20763000999197 - NA2025-03-03 CUSTOM PACK BB2N27R2 5PK CARDIO LN
20763000999753 - NA2025-03-03 CUSTOM PACK 12M79R 10PK TTS
20763000999210 - NA2025-02-28 CUSTOM PACK BB12D77R2 5PK HEAD PACK
20763000999234 - NA2025-02-28 CUSTOM PACK BB12D89R1 5PK HEAD ACC PACK

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