Clarus Digital NeuroPEN Endoscope, 19.0cm 2120-519

GUDID 00810004820494

Clarus Digital NeuroPEN Endoscope, 19.0cm

CLARUS MEDICAL, LLC

Rigid video intracranial/spinal endoscope
Primary Device ID00810004820494
NIH Device Record Key709e2958-5b57-4413-9f64-7b4e2d3fa12b
Commercial Distribution StatusIn Commercial Distribution
Brand NameClarus Digital NeuroPEN Endoscope, 19.0cm
Version Model Number2120-519
Catalog Number2120-519
Company DUNS010316284
Company NameCLARUS MEDICAL, LLC
Device Count1
DM Exempttrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810004820494 [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 Date2024-02-27
Device Publish Date2024-02-19

Devices Manufactured by CLARUS MEDICAL, LLC

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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

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