ChannelScope 2233-002
GUDID 00810004820661
ChannelScope, Long, 21.6cm Working Length
CLARUS MEDICAL, LLC
Rigid optical neuroscope, single-use Rigid optical neuroscope, single-use Rigid optical neuroscope, single-use Rigid optical neuroscope, single-use Rigid optical neuroscope, single-use Rigid optical neuroscope, single-use Rigid optical neuroscope, single-use Rigid optical neuroscope, single-use Rigid optical neuroscope, single-use Rigid optical neuroscope, single-use Rigid optical neuroscope, single-use Rigid optical neuroscope, single-use Rigid optical neuroscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use| Primary Device ID | 00810004820661 |
| NIH Device Record Key | e752f34f-f7b4-41f9-b72c-5aa6d61b8039 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ChannelScope |
| Version Model Number | 2233-002 |
| Catalog Number | 2233-002 |
| 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
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810004820661 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K945633
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 |
On-Brand Devices [ChannelScope]
| 00810004820661 | ChannelScope, Long, 21.6cm Working Length |
| 00810004820654 | ChannelScope, Short, 13.0cm Working Length |
Trademark Results [ChannelScope]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CHANNELSCOPE 78379341 3014072 Dead/Cancelled |
RAZORFISH LLC 2004-03-05 |
 CHANNELSCOPE 74397047 1863546 Dead/Cancelled |
McDATA Corporation 1993-06-02 |
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