NIM-Eclipse

GUDID 00763000384180

COMPUTER 945NCCPUE4 NOTEBOOK

MEDTRONIC SOFAMOR DANEK, INC.

Portable computer Portable computer Portable computer Portable computer Portable computer Portable computer Portable computer Portable computer Portable computer Portable computer Portable computer Portable computer Portable computer

Primary Device ID	00763000384180
NIH Device Record Key	b7008d9a-0a7a-43bc-9347-1cc0aaa1f2ee
Commercial Distribution Status	In Commercial Distribution
Brand Name	NIM-Eclipse
Version Model Number	945NCCPUE4
Company DUNS	830350380
Company Name	MEDTRONIC SOFAMOR DANEK, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
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
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
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
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
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000384180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K061113

FDA Product Code

GWF	STIMULATOR, ELECTRICAL, EVOKED RESPONSE

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-10-30
Device Publish Date	2020-10-22

On-Brand Devices [NIM-Eclipse]

00763000384197	COMPUTER 945NWCPUE4 DESKTOP
00763000384180	COMPUTER 945NCCPUE4 NOTEBOOK
00763000570279	COMPUTER 945NWCPUE4 DESKTOP
00763000570262	COMPUTER 945NCCPUE4 NOTEBOOK

Trademark Results [NIM-Eclipse]

Mark Image Registration \| Serial	Company Trademark Application Date
NIM-ECLIPSE 77155368 3481613 Live/Registered	Medtronic Xomed, Inc. 2007-04-12