ATOMLAB 187-601

GUDID 00718175000021

Thyroid Uptake System, AtomLab 960, 230 VAC

BIODEX MEDICAL SYSTEMS, INC.

Thyroid-uptake nuclear medicine system

• Primary Device ID: 00718175000021
• NIH Device Record Key: fa35a4b7-aaf9-4db9-8c79-3fb9aa359380
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATOMLAB
• Version Model Number: 187-601
• Catalog Number: 187-601
• 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	00718175000021 [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: 2018-07-31
• Device Publish Date: 2018-06-30

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