GammaPro Straight Standard Probe

GUDID B619GPROSTDPROBE0

GammaPro Straight Standard Probe for wireless ionizing radiation detection.

Kubtec

Mobile gamma camera system

• Primary Device ID: B619GPROSTDPROBE0
• NIH Device Record Key: 31a83a9b-81aa-4381-bff3-4253c20b9a47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GammaPro Straight Standard Probe
• Version Model Number: K0018C01
• 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	B619GPROSTDPROBE0 [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

On-Brand Devices [GammaPro Straight Standard Probe]

• B619GPROSTDPROBE0: GammaPro Straight Standard Probe for wireless ionizing radiation detection.
• B619K0018C01UP0: GammaPro Straight Standard Probe for wireless ionizing radiation detection.