LEAD 3778-45 OCTAD 1X8 BNT STYLT EMAN US Medical Device Identification

GUDID 00643169157316

LEAD 3778-45 OCTAD 1X8 BNT STYLT EMAN US

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 ID	00643169157316
NIH Device Record Key	7199be08-146e-4f5b-bdf6-6414fdfba88c
Commercial Distribution Status	In Commercial Distribution
Version Model Number	3778-45
Company DUNS	796986144
Company Name	MEDTRONIC, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com

Device Dimensions

Length	45 Centimeter
Length	45 Centimeter
Length	45 Centimeter

Operating and Storage Conditions

Handling Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169157316 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P840001

FDA Product Code

LGW	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2014-09-23

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