GUDID 00763000812065

WRENCH KIT 5873W TORQUE STERILE MDR

MEDTRONIC, INC.

Pacing/defibrillation lead repair kit Pacing/defibrillation lead repair kit Pacing/defibrillation lead repair kit Pacing/defibrillation lead repair kit Pacing/defibrillation lead repair kit Pacing/defibrillation lead repair kit Pacing/defibrillation lead repair kit Pacing/defibrillation lead repair kit Pacing/defibrillation lead repair kit Pacing/defibrillation lead repair kit Pacing/defibrillation lead repair kit Pacing/defibrillation lead repair kit Pacing/defibrillation lead repair kit Pacing/defibrillation lead repair kit Pacing/defibrillation lead repair kit Pacing/defibrillation lead repair kit Pacing/defibrillation lead repair kit
Primary Device ID00763000812065
NIH Device Record Key2a72fc06-585f-4347-8797-2739de243708
Commercial Distribution StatusIn Commercial Distribution
Version Model Number5873W
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
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 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000812065 [Primary]

FDA Product Code

DTFTOOLS, PACEMAKER SERVICE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-19
Device Publish Date2024-03-11

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.