NeuroPEN 2120-025

GUDID 00810004820678

NeuroPEN, Short, 15.5cm Working Length

CLARUS MEDICAL, LLC

Rigid optical neuroscope, single-use
Primary Device ID00810004820678
NIH Device Record Key24e7ec43-88f0-4f55-a4a7-5b070307f736
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroPEN
Version Model Number2120-025
Catalog Number2120-025
Company DUNS010316284
Company NameCLARUS MEDICAL, LLC
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810004820678 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-20
Device Publish Date2020-07-10

Devices Manufactured by CLARUS MEDICAL, LLC

00810004820173 - Forceps, Cup, Down, 2mm, 28.5cm2025-01-07 Forceps, Cup, Down, 2mm, 28.5cm
00810004820319 - Forceps, Cup with Teeth, 2.0mm x 28.5cm, Down2025-01-07 Forceps, Cup with Teeth, 2.0mm x 28.5cm, Down
00810004820326 - Forceps, Cup with Teeth, 2.0mm x 19.5cm, Down2025-01-07 Forceps, Cup with Teeth, 2.0mm x 19.5cm, Down
00810004820463 - Light Cable, ACMI-ACMI, 1mm2025-01-07 Light Cable, ACMI-ACMI, 1mm
00810004820760 - Forceps, Cup, Down, 2mm, 19.7cm2025-01-07 Forceps, Cup, Down, 2mm, 19.7cm
00810004820777 - Forceps, Grasping, Down, 2mm, 19.7cm2025-01-07 Forceps, Grasping, Down, 2mm, 19.7cm
00810004820784 - Forceps, Grasping, Down, 2mm, 28.5cm2025-01-07 Forceps, Grasping, Down, 2mm, 28.5cm
00810004820876 - Forceps, Grasping, Down, 3mm, 28.5cm2025-01-07 Forceps, Grasping, Down, 3mm, 28.5cm

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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