| Primary Device ID | 08503590070887 | 
| NIH Device Record Key | 8fddb7bf-31d3-49ee-950c-c321887026c3 | 
| Commercial Distribution Discontinuation | 2035-04-30 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | SmartFrame XG TwistPoint Kit w/TE-5 Fr | 
| Version Model Number | CP-NGS-11-TP45-XG-5 | 
| Catalog Number | CP-NGS-11-TP45-XG-5 | 
| Company DUNS | 959181160 | 
| Company Name | CLEARPOINT NEURO, INC. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | false | 
| MRI Safety Status | MR Conditional | 
| Human Cell/Tissue Product | false | 
| Device Kit | true | 
| Device Combination Product | false | 
| Single Use | true | 
| Lot Batch | false | 
| Serial Number | false | 
| 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 | 9499006833 | 
| info@clearpointneuro.com | |
| Phone | 9499006833 | 
| info@clearpointneuro.com | |
| Phone | 9499006833 | 
| info@clearpointneuro.com | |
| Phone | 9499006833 | 
| info@clearpointneuro.com | |
| Phone | 9499006833 | 
| info@clearpointneuro.com | |
| Phone | 9499006833 | 
| info@clearpointneuro.com | |
| Phone | 9499006833 | 
| info@clearpointneuro.com | |
| Phone | 9499006833 | 
| info@clearpointneuro.com | |
| Phone | 9499006833 | 
| info@clearpointneuro.com | |
| Phone | 9499006833 | 
| info@clearpointneuro.com | |
| Phone | 9499006833 | 
| info@clearpointneuro.com | |
| Phone | 9499006833 | 
| info@clearpointneuro.com | |
| Phone | 9499006833 | 
| info@clearpointneuro.com | |
| Phone | 9499006833 | 
| info@clearpointneuro.com | |
| Phone | 9499006833 | 
| info@clearpointneuro.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 08503590070887 [Primary] | 
| HAW | Neurological Stereotaxic Instrument | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2020-10-14 | 
| Device Publish Date | 2020-10-06 | 
| 08503590070887 | A procedure kit that packages several individually boxed and packaged ClearPoint kits together. | 
| 00850359007881 | A procedure kit that packages several individually boxed and packaged ClearPoint kits together. |