StrataMR

GUDID 00643169593442

ASSY 46955 FP SHUNT STRATAMR SMALL

MEDTRONIC PS MEDICAL, INC.

Ventriculo-peritoneal/atrial shunt valve
Primary Device ID00643169593442
NIH Device Record Key3f4e3545-ad46-4b47-a7c6-b739dd804e50
Commercial Distribution StatusIn Commercial Distribution
Brand NameStrataMR
Version Model Number46955
Company DUNS089055867
Company NameMEDTRONIC PS MEDICAL, INC.
Device Count1
DM Exempttrue
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length120 Centimeter
Length120 Centimeter
Length120 Centimeter
Length120 Centimeter
Length120 Centimeter
Length120 Centimeter
Length120 Centimeter
Length120 Centimeter
Length120 Centimeter
Length120 Centimeter
Length120 Centimeter
Length120 Centimeter
Length120 Centimeter
Length120 Centimeter
Length120 Centimeter
Length120 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169593442 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-18

On-Brand Devices [StrataMR]

00643169616486UNISHUNT 46985 FP STRATAMR REG 13.5 VENT
00643169616479UNISHUNT 46975 FP STRATAMR SM 11.5 VENT
00643169616462SHUNT 46970 SNAP STRATAMR REG
00643169616455SHUNT 46960 SNAP STRATAMR SMALL
00643169593442ASSY 46955 FP SHUNT STRATAMR SMALL
00643169593435ASSY 46965 FP SHUNT STRATAMR REGULAR
00763000067571FULL SET 45909SMR STRATAMR ADJUST TOOL
00763000422714VALVE 42965MR STRATAMR II REGULAR
00763000422707VALVE 42955MR STRATAMR II SMALL

Trademark Results [StrataMR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STRATAMR
STRATAMR
85888787 5068940 Live/Registered
Medtronic, Inc.
2013-03-28

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