SPECIFY

GUDID 00613994560322

LEAD 39565-65 SURGICAL LEAD US MNPRO

MEDTRONIC, INC.

Neural-tissue electrical stimulation lead Neural-tissue electrical stimulation lead Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Primary Device ID00613994560322
NIH Device Record Keybfc1f4be-93b9-4912-82f7-b77e2457c6ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPECIFY
Version Model Number39565-65
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 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

Device Dimensions

Length65 Centimeter
Length65 Centimeter
Length65 Centimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994560322 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LGWSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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

On-Brand Devices [SPECIFY]

00613994560322LEAD 39565-65 SURGICAL LEAD US MNPRO
00613994560315LEAD 39286-65 2X8 SURGICAL LEAD US MNPRO
00613994560308LEAD 39286-30 2X8 SURGICAL LEAD US MNPRO
00613994457219LEAD 3998 SPECIFY 20 CM US MKT
00613994287694LEAD SCS 39565-30 5-6-5 SURGICAL MNPRO

Trademark Results [SPECIFY]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPECIFY
SPECIFY
86844162 5147861 Live/Registered
Improcrop U.S.A., Inc.
2015-12-09
SPECIFY
SPECIFY
85026923 not registered Dead/Abandoned
Genuine Parts LLC
2010-04-30
SPECIFY
SPECIFY
77939250 not registered Dead/Abandoned
VACAVA Inc
2010-02-18
SPECIFY
SPECIFY
77734037 3698932 Live/Registered
Medtronic, Inc.
2009-05-11
SPECIFY
SPECIFY
75708281 2693637 Live/Registered
Karsten Manufacturing Corporation
1999-05-17

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