NeuroPEN 2120-025
GUDID 00810004820678
NeuroPEN, Short, 15.5cm Working Length
CLARUS MEDICAL, LLC
Rigid optical neuroscope, single-use| Primary Device ID | 00810004820678 |
| NIH Device Record Key | 24e7ec43-88f0-4f55-a4a7-5b070307f736 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeuroPEN |
| Version Model Number | 2120-025 |
| Catalog Number | 2120-025 |
| Company DUNS | 010316284 |
| Company Name | CLARUS MEDICAL, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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
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 |
| 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 |
| 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 | 00810004820678 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K942249
FDA Product Code
| GWG | Endoscope, Neurological |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-20 |
| Device Publish Date | 2020-07-10 |
Devices Manufactured by CLARUS MEDICAL, LLC
| 10810004821030 - Clarus Digital Inspection Scope, 1mm x 110cm, High Definition | 2024-02-28 Clarus Digital Inspection Scope, 1mm x 110cm, High Definition |
| 00810004820012 - Clarus Digital ChannelScope Endoscope, 13.0cm | 2024-02-27 Clarus Digital ChannelScope Endoscope, 13.0cm |
| 00810004820357 - Clarus Digital NeuroPEN Endoscope, 15.5cm | 2024-02-27 Clarus Digital NeuroPEN Endoscope, 15.5cm |
| 00810004820395 - Clarus Digital ChannelScope Endoscope, 11.0cm | 2024-02-27 Clarus Digital ChannelScope Endoscope, 11.0cm |
| 00810004820494 - Clarus Digital NeuroPEN Endoscope, 19.0cm | 2024-02-27 Clarus Digital NeuroPEN Endoscope, 19.0cm |
| 00810004821026 - Clarus Digital ClarusScope Endoscope | 2024-02-27 Clarus Digital ClarusScope Endoscope |
| 00810004821019 - Clarus Digital Control Module | 2024-02-27 Clarus Digital Control Module |
| 00810004820005 - Clarus Digital Inspection Scope, 1.9mm OD | 2022-07-29 The Clarus Inspection Scope is a device with a flexible working length intended for the visual examination of the lumen of an in |
Trademark Results [NeuroPEN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEUROPEN 75292296 2215863 Live/Registered |
Owen Mumford Limited 1997-05-15 |
 NEUROPEN 75082984 2037241 Dead/Cancelled |
Clarus Medical Systems, Inc. 1996-04-03 |
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