NeuroPEN

GUDID 00613994840233

NEUROPEN 2120-025 15MM 15.5 DF .045

MEDTRONIC PS MEDICAL, INC.

Rigid optical neuroscope, single-use
Primary Device ID00613994840233
NIH Device Record Keybc743f6a-d0c9-47e7-9280-4c5ef717a7ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroPEN
Version Model Number2120-025
Company DUNS089055867
Company NameMEDTRONIC PS MEDICAL, 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 Usetrue
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
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

Device Dimensions

Length15.5 Centimeter
Length15.5 Centimeter
Length15.5 Centimeter
Length15.5 Centimeter
Length15.5 Centimeter
Length15.5 Centimeter
Length15.5 Centimeter
Length15.5 Centimeter
Length15.5 Centimeter
Length15.5 Centimeter
Length15.5 Centimeter
Length15.5 Centimeter
Length15.5 Centimeter
Length15.5 Centimeter
Length15.5 Centimeter
Length15.5 Centimeter
Length15.5 Centimeter
Length15.5 Centimeter
Length15.5 Centimeter
Length15.5 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994840233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWGENDOSCOPE, NEUROLOGICAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2016-06-13

On-Brand Devices [NeuroPEN]

00613994908490NEUROPEN 2120-035 15MM 19CM DF
00613994840233NEUROPEN 2120-025 15MM 15.5 DF .045
00643169498051FORCEPS 3220-001 BIOPSY 3MM L 28.5CM
00721902879784NEUROPEN 27769 W/NO EPOXY OVER END

Trademark Results [NeuroPEN]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NEUROPEN
NEUROPEN
75292296 2215863 Live/Registered
Owen Mumford Limited
1997-05-15
NEUROPEN
NEUROPEN
75082984 2037241 Dead/Cancelled
Clarus Medical Systems, Inc.
1996-04-03

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