GUDID 00613994755544

ACCY PH-2510 REPLCMNT STRAP & PAD MDD

MEDTRONIC, INC.

Neurological stereotactic surgery system
Primary Device ID00613994755544
NIH Device Record Key3138a5cd-3b46-4f81-bb1c-aad14e23379f
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberPH-2510
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
GS100613994755544 [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 Date2015-11-18

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