GUDID 00613994342935

PROG 37743 PATIENT ULTRA US MKT

MEDTRONIC, INC.

Multiple active implantable device programmer
Primary Device ID00613994342935
NIH Device Record Keyba10bf89-0ffd-4406-92fd-c6c7aa140126
Commercial Distribution Discontinuation2018-09-26
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number37743
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 Usefalse
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994342935 [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 Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-10-22
Device Publish Date2014-09-23

Devices Manufactured by MEDTRONIC, INC.

20199150023800 - NA2025-06-09 CUSTOM PACK BB11X70R1 5PK AV LOOP
20199150023824 - NA2025-06-09 CUSTOM PACK BB8A44R4 4PK HBC MYO
20199150024135 - NA2025-06-09 CUSTOM PACK BB11A07R2 5PK BRIDGE LINE
00613994163523 - Duran AnCore2025-06-09 TOOL 7620HXL HANDLE DURAN ANCORE 14L
00613994959546 - Open Pivot™2025-06-09 ACCY 558 ACTUATOR PACKAGE AVG
00643169402539 - MOSAIC ULTRA™2025-06-09 SIZERS 7308U MOSAIC ULTRA AORTIC 26L
00643169402591 - MOSAIC™CINCH™2025-06-09 SIZERS 7308C MOSAIC CINCH AORTIC 26L
00643169525511 - CG Future™2025-06-09 SIZER SET 7638S CG FUTURE 26L

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