GUDID 00763000004989

ACCY KIT DB-5000 STMLOC CLIP ASSEMBLY

MEDTRONIC, INC.

Neurosurgical headrest
Primary Device ID00763000004989
NIH Device Record Keydb269cae-546f-4df4-99a1-9eb5ef2088c8
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberDB-5000
Company DUNS796986144
Company NameMEDTRONIC, INC.
Device Count5
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
GS100763000004989 [Primary]
GS170763000004988 [Unit of Use]

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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00763000953423 - NA2024-05-31 CUSTOM PACK BB12F51R2 E ASSIST PACK
00763000953614 - NA2024-05-31 CUSTOM PACK HY0A20R46 CHRST NN

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