Primary Device ID | B619X80QT0 |
NIH Device Record Key | abc93d09-070a-450e-a011-e06de2bbc8b3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | XPERT80 |
Version Model Number | XPERT 80 |
Company DUNS | 361955128 |
Company Name | Kubtec |
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 | 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 | 2033648544 |
apangaio@kubtec.com | |
Phone | 2033648544 |
apangaio@kubtec.com | |
Phone | 2033648544 |
apangaio@kubtec.com | |
Phone | 2033648544 |
apangaio@kubtec.com | |
Phone | 2033648544 |
apangaio@kubtec.com | |
Phone | 2033648544 |
apangaio@kubtec.com | |
Phone | 2033648544 |
apangaio@kubtec.com | |
Phone | 2033648544 |
apangaio@kubtec.com | |
Phone | 2033648544 |
apangaio@kubtec.com | |
Phone | 2033648544 |
apangaio@kubtec.com | |
Phone | 2033648544 |
apangaio@kubtec.com | |
Phone | 2033648544 |
apangaio@kubtec.com | |
Phone | 2033648544 |
apangaio@kubtec.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B619X80QT0 [Primary] |
MWP | Cabinet,X-Ray System |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-04-03 |
Device Publish Date | 2025-03-26 |
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 |