| Primary Device ID | B619GPROSTDKIT0 |
| NIH Device Record Key | 78893344-7fcd-4538-ad96-83ec90a35b4f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GammaPro Standard Probe with Tablet Carry Case |
| Version Model Number | K0018C02 |
| Company DUNS | 361955128 |
| Company Name | Kubtec |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B619GPROSTDKIT0 [Primary] |
| IZD | Probe, Uptake, Nuclear |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-24 |
| Device Publish Date | 2022-10-14 |
| B619K0018C01UP0 - GammaPro Straight Standard Probe | 2025-04-03 GammaPro Straight Standard Probe for wireless ionizing radiation detection. |
| B619K0019C01UW0 - GammaPro High Sensitivity Probe | 2025-04-03 GammaPro High Sensitivity Probe used for wireless ionizing radiation detection. |
| B619K0020C01TA0 - GammaPro Laparoscopic Probe | 2025-04-03 GammaPro Laparoscopic Probe used for wireless ionizing radiation detection. |
| B619K0021C01TH0 - GammaPro Angled Standard Probe | 2025-04-03 GammaPro Angled Standard Probe used for wireless ionizing radiation detection. |
| B619X20Q9 - XPERT20 | 2025-04-03 specimen x-ray system |
| B619X40QF0 - XPERT40 | 2025-04-03 Specimen x-ray system |
| B619X42QK0 - XPERT42 | 2025-04-03 Specimen x-ray system |
| B619X80LAR0 - XPERT80L | 2025-04-03 Specimen x-ray system |