GUDID 00763000004972

ACCY 3550S-02 STIMLOC DISPSBL SCREWDRVER

MEDTRONIC, INC.

Neurosurgical procedure kit, non-medicated, single-use
Primary Device ID00763000004972
NIH Device Record Key6cecc4e1-c23f-4dad-9dc0-da819d8507f1
Commercial Distribution StatusIn Commercial Distribution
Version Model Number3550S-02
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000004972 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXRCOVER, BURR HOLE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-21
Device Publish Date2019-05-13

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