GUDID 00673978233369

KIT 20034 EDM VENTRICULAR 35CM

MEDTRONIC PS MEDICAL, INC.

Ventricular cerebrospinal fluid drainage catheterization kit
Primary Device ID00673978233369
NIH Device Record Key0f2843c2-cf71-4ea2-a73f-0ed563359042
Commercial Distribution StatusIn Commercial Distribution
Version Model Number20034
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 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
GS100673978233369 [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 Date2015-07-14

Devices Manufactured by MEDTRONIC PS MEDICAL, INC.

00763000422622 - StrataMR II2024-11-05 VALVE 42955MR STRATAMR II SMALL CE
00763000422639 - StrataMR II2024-11-05 VALVE 42965MR STRATAMR II REGULAR CE
00763000467364 - BECKER SYSTEMS2024-07-01 EDMS 27931 BECKER GS TUBING SMARTSITES
00763000467401 - NA2024-06-10 CONNECTOR 9041 LUERLOCK TO FIT 1.3MM ID
00763000529338 - Becker External Drainage and Monitoring System2024-05-27 BECKER 27761 STOP BCNDLESS PATLN 24
00763000406073 - Becker2024-04-08 EDMS 46128 BECKER II BLUE PT LN
00763000467340 - NA2024-03-11 KIT 46442 EDM LUMBAR DRN CLS TIP 5PK
00763000406042 - NA2024-03-05 ASSEMBLY 46422 EDM DRAINAGE

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.