GUDID 00643169919396

HEADREST PH-2500 PASSIVE NEXFR GLBL MKT

MEDTRONIC, INC.

Neurosurgical headrest
Primary Device ID00643169919396
NIH Device Record Keybfb9cd88-9d7f-423f-a8f5-d02bc67bb91b
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberPH-2500
Company DUNS796986144
Company NameMEDTRONIC, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
GS100643169919396 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBLHOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

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 Date2017-12-18

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