GUDID 00681490148818

LEAD 6721S-50 PATCH UNI EPI DF-1 W/MANF

MEDTRONIC, INC.

Endocardial defibrillation lead
Primary Device ID00681490148818
NIH Device Record Keya7cf0357-00bc-4d17-84ef-98bd4a946d4a
Commercial Distribution StatusIn Commercial Distribution
Version Model Number6721S-50
Company DUNS006261481
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 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
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

Device Dimensions

Length50 Centimeter
Length50 Centimeter
Length50 Centimeter
Length50 Centimeter
Length50 Centimeter
Length50 Centimeter
Length50 Centimeter
Length50 Centimeter
Length50 Centimeter
Length50 Centimeter
Length50 Centimeter
Length50 Centimeter
Length50 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100681490148818 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWSImplantable cardioverter defibrillator (non-CRT)

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.

00763000893910 - SHERPA NX BALANCED™2024-12-20 CATHETER SB6FL40SH SB 6F 100CM FL40
00763000893941 - SHERPA NX BALANCED™2024-12-20 CATHETER SB6FR40SH SB 6F 100CM FR40
00763000988258 - NA2024-12-20 CUSTOM PACK BB10Q85R1 FILTER
00763000988760 - NA2024-12-20 CUSTOM PACK BB1F66R26 CASPER
00763000973391 - Sphere-9™ Catheter2024-12-16 CATHETER AFR-00001 SPHERE 9 Q-US AFR
00763000986704 - NA2024-12-09 CUSTOM PACK BB7J97R20 1/4 PED CIRC
00763000986773 - NA2024-12-09 CUSTOM PACK BB11N26R12 MASTER PACK
20763000986814 - NA2024-12-09 CUSTOM PACK BB12G70R3 10PK SUPPLIES

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