GUDID 00763000875770

CNTRL 97745-RFB INTELLIS PTM REFURB US

MEDTRONIC, INC.

Multiple active implantable device programmer
Primary Device ID00763000875770
NIH Device Record Keyd40fc4ec-5aea-4eaf-9bf8-9321fc79364f
Commercial Distribution StatusIn Commercial Distribution
Version Model Number97745-RFB
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
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
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 -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Celsius and 58 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000875770 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QRBStimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-24
Device Publish Date2023-11-16

Devices Manufactured by MEDTRONIC, INC.

00763000835392 - HawkOne™2025-01-06 ATHERECTOMY H1-14550 CUTTER DRIVER UNI
00763000989224 - NA2025-01-06 CUSTOM PACK BB12B64R6 GOLD H/L PACK
00763000990060 - NA2025-01-06 CUSTOM PACK BB12M44R UMCEP SHUNT PK
20763000990088 - NA2025-01-06 CUSTOM PACK 9D70R2 10PK HDR PK
20763000990460 - NA2025-01-06 CUSTOM PACK BB12M56R 10PK 1/4 SUPPLEMENT
20763000990484 - NA2025-01-06 CUSTOM PACK BB12M39R 2PK PACK C STRAIGH
20763000990507 - NA2025-01-06 CUSTOM PACK 11C82R1 4PK CARDIOPLEG
00763000990510 - NA2025-01-06 CUSTOM PACK BB11Y33R6 PED SM ADT

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