GUDID 00643169072664

KIT 8543 ISOMED CAP IP20.1 PUMP US MKT

MEDTRONIC, INC.

Neurosurgical procedure kit, non-medicated, single-use
Primary Device ID00643169072664
NIH Device Record Key40faf780-fad8-4731-b7d1-4a5c650d2465
Commercial Distribution StatusIn Commercial Distribution
Version Model Number8543
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
GS100643169072664 [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

Devices Manufactured by MEDTRONIC, INC.

00199150007189 - NA2025-05-09 CUSTOM PACK BB10Y89R16 ECC 3/8 A/V
00199150014347 - NA2025-05-09 CUSTOM PACK BB11L88R7 SUPPRT SM
20199150003734 - NA2025-05-06 CUSTOM PACK BB10C88R1 5PK PRIME KIT
00199150008698 - NA2025-05-06 CUSTOM PACK BB11A81R6 RWJ PEDIMAG
20199150009200 - NA2025-05-06 CUSTOM PACK BB4G73R2 25PK PRT ACCSP
00199150009213 - NA2025-05-06 CUSTOM PACK BB11L40R5 UCD SM ADLT
00199150009251 - NA2025-05-06 CUSTOM PACK BB4Z56R7 CSP L SUP
00199150009268 - NA2025-05-06 CUSTOM PACK BB12P00R3 SUTTER MCS

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.