| Primary Device ID | 00810004821019 |
| NIH Device Record Key | 360c4eb5-404c-48a9-a9f4-56a369648f5d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Clarus Digital Control Module |
| Version Model Number | 5190-500 |
| Catalog Number | 5190-500 |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 763-525-8400 |
| admin@clarus-medical.com | |
| Phone | 763-525-8400 |
| admin@clarus-medical.com | |
| Phone | 763-525-8400 |
| admin@clarus-medical.com | |
| Phone | 763-525-8400 |
| admin@clarus-medical.com | |
| Phone | 763-525-8400 |
| admin@clarus-medical.com | |
| Phone | 763-525-8400 |
| admin@clarus-medical.com | |
| Phone | 763-525-8400 |
| admin@clarus-medical.com | |
| Phone | 763-525-8400 |
| admin@clarus-medical.com | |
| Phone | 763-525-8400 |
| admin@clarus-medical.com | |
| Phone | 763-525-8400 |
| admin@clarus-medical.com | |
| Phone | 763-525-8400 |
| admin@clarus-medical.com | |
| Phone | 763-525-8400 |
| admin@clarus-medical.com | |
| Phone | 763-525-8400 |
| admin@clarus-medical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810004821019 [Direct Marking] |
| GS1 | 10810004821016 [Primary] |
| GWG | Endoscope, Neurological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-27 |
| Device Publish Date | 2024-02-19 |
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| 00810004821026 - Clarus Digital ClarusScope Endoscope | 2024-02-27 Clarus Digital ClarusScope Endoscope |
| 00810004821019 - Clarus Digital Control Module | 2024-02-27Clarus Digital Control Module |
| 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 |