ATOMLAB 187-602

GUDID 00718175000137

Thyroid Uptake System, Well Counter

BIODEX MEDICAL SYSTEMS, INC.

Thyroid-uptake nuclear medicine system

• Primary Device ID: 00718175000137
• NIH Device Record Key: d71ef908-9f9a-4b17-93c3-ecff9c81b956
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATOMLAB
• Version Model Number: 187-602
• Catalog Number: 187-602
• Company DUNS: 043833813
• Company Name: BIODEX MEDICAL SYSTEMS, INC.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00718175000137 [Primary]

FDA Product Code

• IZD: Probe, Uptake, Nuclear

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-27
• Device Publish Date: 2019-10-16

On-Brand Devices [ATOMLAB]

• 00718175000021: Thyroid Uptake System, AtomLab 960, 230 VAC
• 00718175000014: Thyroid Uptake System, AtomLab 960, 120 VAC
• 00718175000137: Thyroid Uptake System, Well Counter