GUDID 00763000875787

BATTERY 97755BP-RFB INTLLS BAT PK RFB US

MEDTRONIC, INC.

Noninvasive device battery charger
Primary Device ID00763000875787
NIH Device Record Key20b38c54-b992-4401-a434-b79c87f45827
Commercial Distribution StatusIn Commercial Distribution
Version Model Number97755BP-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

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000875787 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-24
Device Publish Date2023-11-16

Devices Manufactured by MEDTRONIC, INC.

00763000613617 - Mosaic™7308C2025-03-11 SIZERS 7308C MOSAIC CINCH AORTIC MDR
00763000613624 - Mosaic Ultra™7308U2025-03-11 SIZERS 7308U MOSAIC ULTRA AORTIC MDR
00763000613631 - Mosaic™73102025-03-11 OBTURATORS 7310 MOSAIC MITRAL MDR
00763000613648 - NA2025-03-11 HANDLE 7639 VALVE MDR
00763000613655 - NA2025-03-11 HANDLE 7639XL VALVE XL MDR
00763000613662 - NA2025-03-11 ACCESSORY 7642 LOCK NUT MDR
00763000614034 - Hancock™ II 75052025-03-11 OBTURATOR 7505SET HK II AORTIC MDR
00763000614041 - Hancock™ II 75102025-03-11 OBTURATOR 7510SET HK II MITRAL MDR

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