Captus 4000e Thyroid Uptake System with Well 5430-30152

GUDID 00859942006102

The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, Bioassay module, Wipe Test Module, and Lab Tests.

CAPINTEC, INC.

Thyroid-uptake nuclear medicine system

• Primary Device ID: 00859942006102
• NIH Device Record Key: 528e5b6a-38fe-4abe-98db-c17e167d0a12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Captus 4000e Thyroid Uptake System with Well
• Version Model Number: Captus 4000e Thyroid System with Well
• Catalog Number: 5430-30152
• Company DUNS: 047684501
• Company Name: CAPINTEC, 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

Customer Support Contacts

• Phone: 201-825-9500
• Email: getinfo@capintec.com
• Phone: 201-825-9500
• Email: getinfo@capintec.com
• Phone: 201-825-9500
• Email: getinfo@capintec.com
• Phone: 201-825-9500
• Email: getinfo@capintec.com
• Phone: 201-825-9500
• Email: getinfo@capintec.com
• Phone: 201-825-9500
• Email: getinfo@capintec.com
• Phone: 201-825-9500
• Email: getinfo@capintec.com
• Phone: 201-825-9500
• Email: getinfo@capintec.com
• Phone: 201-825-9500
• Email: getinfo@capintec.com
• Phone: 201-825-9500
• Email: getinfo@capintec.com
• Phone: 201-825-9500
• Email: getinfo@capintec.com
• Phone: 201-825-9500
• Email: getinfo@capintec.com
• Phone: 201-825-9500
• Email: getinfo@capintec.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859942006102 [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: 2018-07-12
• Device Publish Date: 2018-06-11

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