GUDID 00613994908216

RES 23038 B NEONATE W/INT RA CATH 30

MEDTRONIC PS MEDICAL, INC.

Cranial port/reservoir Cranial port/reservoir
Primary Device ID00613994908216
NIH Device Record Keyd0baaa7c-0ff1-453c-b23e-99db6cd1f046
Commercial Distribution StatusIn Commercial Distribution
Version Model Number23038 B
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 Dimensions

Length3 Centimeter
Length3 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994908216 [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 Date2015-06-17

Devices Manufactured by MEDTRONIC PS MEDICAL, INC.

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
00763000406080 - NA2024-03-05 DRAIN 27302 EDM LUMBAR W/120 GRAD CH
00763000431259 - Becker2024-03-05 EDMS 46129 EURO BECKER II BLUE PT LN
00763000529307 - Becker2024-03-05 BECKER 27609 W/NEEDLESLESS INJ. SITE
00763000529369 - Becker2024-03-05 KIT 25068 EDM 46124 46126
00763000467357 - NA2024-03-05 KIT 46441 EDM LUMBAR DRAINAGE 5PK

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