StrataMR II

GUDID 00763000422622

VALVE 42955MR STRATAMR II SMALL CE

MEDTRONIC PS MEDICAL, INC.

Cerebrospinal fluid shunt valve
Primary Device ID00763000422622
NIH Device Record Key1eddf3e4-35bc-4b35-a094-7820f2f8658a
Commercial Distribution StatusIn Commercial Distribution
Brand NameStrataMR II
Version Model Number42955MR
Company DUNS089055867
Company NameMEDTRONIC PS MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
GS100763000422622 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JXGShunt, central nervous system and components

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-05
Device Publish Date2024-10-28

On-Brand Devices [StrataMR II]

00763000422639VALVE 42965MR STRATAMR II REGULAR CE
00763000422622VALVE 42955MR STRATAMR II SMALL CE

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