GUDID 20613994393054

ACC 042294 BULK INTRODUCER KIT US

MEDTRONIC, INC.

Neurosurgical procedure kit, non-medicated, single-use
Primary Device ID20613994393054
NIH Device Record Key1c885700-1b78-4b16-92c9-72d02ab73fe4
Commercial Distribution StatusIn Commercial Distribution
Version Model Number042294
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994393050 [Primary]
GS120613994393054 [Package]
Contains: 00613994393050
Package: PK [6 Units]
In Commercial Distribution

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

Devices Manufactured by MEDTRONIC, INC.

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00199150042753 - NA2025-09-08 CUSTOM PACK BB9F06R5 EVL WCH NEONA
00199150043392 - NA2025-09-08 CUSTOM PACK BB12D74R5 HLO ALLIDON
00199150043507 - NA2025-09-08 CUSTOM PACK BB12Q89R1 EVL 3/8
00199150043538 - NA2025-09-08 CUSTOM PACK BB12Q60R1 HLO ST BERNAR
00199150044436 - NA2025-09-08 CUSTOM PACK BB9R01R23 HLN OR PEDIA
20199150044454 - NA2025-09-08 CUSTOM PACK BB12R78R 5PK ACC PDEVL

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