GammaPro High Sensitivity Probe

GUDID B619GPROHISPROBE0

GammaPro High Sensitivity Probe used for wireless ionizing radiation detection.

Kubtec

Mobile gamma camera system

• Primary Device ID: B619GPROHISPROBE0
• NIH Device Record Key: 7e9660f9-6d10-41e7-8883-f8da64e74599
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GammaPro High Sensitivity Probe
• Version Model Number: K0019C01
• 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	B619GPROHISPROBE0 [Primary]

FDA Product Code

• IZD: Probe, Uptake, Nuclear

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-24
• Device Publish Date: 2022-10-14

Devices Manufactured by Kubtec

• B619GPROHISKIT0 - GammaPro Hi-Sense Probe with Tablet and Carry Case: 2022-10-24 GammaPro Hi-Sense Probe with Tablet and Carry Case used for wireless ionizing radiation detection.
• B619GPROHISPROBE0 - GammaPro High Sensitivity Probe: 2022-10-24GammaPro High Sensitivity Probe used for wireless ionizing radiation detection.
• B619GPROHISPROBE0 - GammaPro High Sensitivity Probe: 2022-10-24 GammaPro High Sensitivity Probe used for wireless ionizing radiation detection.
• B619GPROLAPKIT0 - GammaPro Laparoscopic Probe with Tablet and Carry Case: 2022-10-24 GammaPro Laparoscopic Probe with Tablet and Carry Case used for wireless ionizing radiation detection.
• B619GPROLAPPROBE0 - GammaPro Laparoscopic Probe: 2022-10-24 GammaPro Laparoscopic Probe used for wireless ionizing radiation detection.
• B619GPROSTDANGPROBE0 - GammaPro Angled Standard Probe: 2022-10-24 GammaPro Angled Standard Probe used for wireless ionizing radiation detection.
• B619GPROSTDKIT0 - GammaPro Standard Probe with Tablet Carry Case: 2022-10-24 GammaPro Kit with Standard probe, Tablet and Carry Case used for wireless ionizing radiation detection.
• B619GPROSTDPROBE0 - GammaPro Straight Standard Probe: 2022-10-24 GammaPro Straight Standard Probe for wireless ionizing radiation detection.
• B619GPROCASETABL2 - GammaPro Carry Case and Tablet: 2022-10-13 Table with installed software is used with wireless battery powered probes (different shapes and sizes) to detect a determined r