XPERT84

GUDID B619X84R3

Tissue specimen x-ray system IVD

Primary Device ID	B619X84R3
NIH Device Record Key	6e34eeaf-bb00-447d-92b5-85a877e22bad
Commercial Distribution Status	In Commercial Distribution
Brand Name	XPERT84
Version Model Number	XPERT84
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

Device Issuing Agency	Device ID
HIBCC	B619X84R3 [Primary]

MWP	Cabinet,X-Ray System

Steralize Prior To Use	false
Device Is Sterile	false

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