GUDID 00643169887664

CATH 8731SC INTRTHCL SUTRLESS CNNCTR FWU

MEDTRONIC, INC.

Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit
Primary Device ID00643169887664
NIH Device Record Key0390a1a7-eeed-4ffd-8bf1-fa5157f3eebf
Commercial Distribution StatusIn Commercial Distribution
Version Model Number8731SC
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 Producttrue
Single Usetrue
Lot Batchfalse
Serial Numbertrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169887664 [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 Number4
Public Version Date2019-08-09
Device Publish Date2017-07-08

Devices Manufactured by MEDTRONIC, INC.

00763000957544 - NA2024-06-28 CUSTOM PACK BB7J30R4 LIV SHUNT
00763000957551 - NA2024-06-28 CUSTOM PACK BBB7S09R13 SUPPRT SM
20763000957760 - NA2024-06-28 CUSTOM PACK BB12G13R 5PK FL MEM MANIFOL
00763000957780 - NA2024-06-28 CUSTOM PACK 11H88R7 ACCESSORY PACK
00763000958015 - NA2024-06-28 CUSTOM PACK HY11R06R2 SUPP 1/4 PK
20763000958033 - NA2024-06-28 CUSTOM PACK BB9B82R2 5PK JUMP PACK
00763000958695 - NA2024-06-28 CUSTOM PACK BB11F32R5 ACCESSORY 1/4
00763000958701 - NA2024-06-28 CUSTOM PACK BB12F79R2 NT PK

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