InvisX

GUDID 00643169497788

INSTRUMENT 60720 INVISX TRIMMING REU

MEDTRONIC PS MEDICAL, INC.

General internal orthopaedic fixation system implantation kit
Primary Device ID00643169497788
NIH Device Record Key35a615d5-80a9-42c0-b9e7-ca496515e3ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameInvisX
Version Model Number60720
Company DUNS089055867
Company NameMEDTRONIC PS MEDICAL, 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 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
GS100643169497788 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXNPLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00643169497788]

Moist Heat or Steam Sterilization


[00643169497788]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-05

Devices Manufactured by MEDTRONIC PS MEDICAL, INC.

00763000950941 - Duet EDMS2025-03-31 EDMS 46913 DUET INTERLINK SITES/US
00763000950972 - Duet EDMS2025-03-31 EDMS 46914 DUET BLUECORE SITES/US
00763000281243 - Exacta Pole Clamp with laser level2025-02-25 CLAMP 46715 EXACTA PL NEG 25CM W/LSR
00763000281229 - Exacta Pole Clamp with laser level2025-02-24 ASSY 46711 EXACTA POLE CLAMP W/LASER
00763000413255 - Exacta™2025-02-10 ASSY 46711 EXACTA POLE CLAMP W/LASER
00763000413262 - Exacta™2025-02-10 CLAMP 46715 EXACTA PL NEG 25CM W/LSR
00763000422653 - Valve, StrataMR II, Regular2025-01-31 ASSY 46965MR SHUNT STRATAMR II REG CE
00763000422677 - Snap Shunt Assembly, StrataMR II, Regular2025-01-31 SHUNT 46966MR SNP ASSY STRATAMRII REG CE

Trademark Results [InvisX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INVISX
INVISX
78043473 2660838 Live/Registered
Medtronic, Inc.
2001-01-17

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