ISOMED ®

GUDID 00681490184311

KIT 8553 ISOMED DOMESTC

MEDTRONIC, INC.

Neurosurgical procedure kit, non-medicated, single-use
Primary Device ID00681490184311
NIH Device Record Key9ff57a6e-3098-4d80-8d4c-7505ac4e1b45
Commercial Distribution StatusIn Commercial Distribution
Brand NameISOMED ®
Version Model Number8553
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
GS100681490184311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKKPUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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 Date2014-09-23

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00199150019908 - NA2025-06-02 CUSTOM PACK BB8T55R4 1/4 SUPP
00199150019915 - NA2025-06-02 CUSTOM PACK BB5227R13 ASSIST

Trademark Results [ISOMED]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ISOMED
ISOMED
77362690 3495293 Dead/Cancelled
Fishel, Mark A
2008-01-02
ISOMED
ISOMED
75458290 2300819 Live/Registered
Medtronic, Inc.
1998-03-27
ISOMED
ISOMED
74564312 not registered Dead/Abandoned
Power Quality, Inc.
1994-08-22
ISOMED
ISOMED
74503156 not registered Dead/Abandoned
Medtronic, Inc.
1994-03-17

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