Clear-Site®

GUDID 00613994450661

EDMS 46918 CLEAR-SITE LASER LEVEL

MEDTRONIC PS MEDICAL, INC.

Laser patient positioning system
Primary Device ID00613994450661
NIH Device Record Key3c014941-a11c-4bed-bc2d-a3b457856e0c
Commercial Distribution StatusIn Commercial Distribution
Brand NameClear-Site®
Version Model Number46918
Company DUNS089055867
Company NameMEDTRONIC PS MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994450661 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JXGShunt, central nervous system and components

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-07-16

On-Brand Devices [Clear-Site®]

00613994450661EDMS 46918 CLEAR-SITE LASER LEVEL
00643169497955EDMS 46918 CLEAR-SITE LASER LEVEL
00763000169893EDMS 46918 CLEAR-SITE LASER LEVEL
00763000281267EDMS 46918 CLEAR-SITE LASER LEVEL

Trademark Results [Clear-Site]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CLEAR-SITE
CLEAR-SITE
77409429 3683901 Live/Registered
Medtronic, Inc.
2008-02-29
CLEAR-SITE
CLEAR-SITE
74289002 1820534 Live/Registered
AVENT, INC.
1992-06-29

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