| Primary Device ID | B971CT400 |
| NIH Device Record Key | cfa5ba7d-09aa-4663-8688-8e935927512e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CTMark |
| Version Model Number | 4.0mm CT ball on label |
| Company DUNS | 055127831 |
| Company Name | Jessop Precision Products Inc. |
| Device Count | 50 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Phone | 800-406-3399 |
| orders@suremark.com | |
| Phone | 800-406-3399 |
| orders@suremark.com | |
| Phone | 800-406-3399 |
| orders@suremark.com | |
| Phone | 800-406-3399 |
| orders@suremark.com | |
| Phone | 800-406-3399 |
| orders@suremark.com | |
| Phone | 800-406-3399 |
| orders@suremark.com | |
| Phone | 800-406-3399 |
| orders@suremark.com | |
| Phone | 800-406-3399 |
| orders@suremark.com | |
| Phone | 800-406-3399 |
| orders@suremark.com | |
| Phone | 800-406-3399 |
| orders@suremark.com | |
| Phone | 800-406-3399 |
| orders@suremark.com | |
| Phone | 800-406-3399 |
| orders@suremark.com | |
| Phone | 800-406-3399 |
| orders@suremark.com | |
| Phone | 800-406-3399 |
| orders@suremark.com | |
| Phone | 800-406-3399 |
| orders@suremark.com | |
| Phone | 800-406-3399 |
| orders@suremark.com | |
| Phone | 800-406-3399 |
| orders@suremark.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B971CT400 [Unit of Use] |
| HIBCC | B971CT401 [Primary] |
| JAC | System, X-Ray, Film Marking, Radiographic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-18 |
| Device Publish Date | 2021-10-08 |
| B971CTO0 | CT Circle on label |
| B971CTCR30 | 1.2cm (0.5 inch) CT Cross on Round Label |
| B971CT400 | 4.0mm CT ball on label |
| B971CT230 | 2.3mm CT ball on label |