ClearPoint PURSUIT MCA-53-250
GUDID 00850359007683
MR Compatible Aspiration Kit, 5.3 mm OD x 250 mm Length
CLEARPOINT NEURO, INC.
General-purpose endoscopic needle, single-use| Primary Device ID | 00850359007683 |
| NIH Device Record Key | 480824ef-81c8-431d-882e-d525bbda7b7f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ClearPoint PURSUIT |
| Version Model Number | MCA-53-250 |
| Catalog Number | MCA-53-250 |
| Company DUNS | 959181160 |
| Company Name | CLEARPOINT NEURO, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
| Outer Diameter | 5.3 Millimeter |
Operating and Storage Conditions
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850359007683 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K181731
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 | 2021-02-01 |
| Device Publish Date | 2021-01-22 |
On-Brand Devices [ClearPoint PURSUIT]
| 08503590070726 | MCA Kit, 6.6 mm OD x 250 mm Length |
| 08503590070719 | MCA Kit, 6.6 mm OD x 300 mm Length |
| 08503590070702 | MCA Kit, 5.9 mm OD x 250 mm Length |
| 08503590070696 | MCA Kit, 5.9 mm OD x 300 mm Length |
| 08503590070689 | MR Compatible Aspiration Kit, 5.3 mm OD x 250 mm Length |
| 08503590070672 | MR Compatible Aspiration Kit, 5.3 mm OD x 300 mm Length |
| 00850359007720 | MCA Kit, 6.6 mm OD x 250 mm Length |
| 00850359007713 | MCA Kit, 6.6 mm OD x 300 mm Length |
| 00850359007706 | MCA Kit, 5.9 mm OD x 250 mm Length |
| 00850359007690 | MCA Kit, 5.9 mm OD x 300 mm Length |
| 00850359007683 | MR Compatible Aspiration Kit, 5.3 mm OD x 250 mm Length |
| 00850359007676 | MR Compatible Aspiration Kit, 5.3 mm OD x 300 mm Length |
Trademark Results [ClearPoint PURSUIT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLEARPOINT PURSUIT 88011012 5869454 Live/Registered |
MRI Interventions, Inc. 2018-06-22 |
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