AtamA™ System ATF103

GUDID 00816589020212

AtamA Head Fixation (3 piece)

MONTERIS MEDICAL INC

Radiological headrest

• Primary Device ID: 00816589020212
• NIH Device Record Key: a4a3a476-300f-4264-8b5f-43f63e5206e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AtamA™ System
• Version Model Number: 20607
• Catalog Number: ATF103
• Company DUNS: 021415875
• Company Name: MONTERIS MEDICAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(866)799-7655
• Email: info@monteris.com
• Phone: +1(866)799-7655
• Email: info@monteris.com
• Phone: +1(866)799-7655
• Email: info@monteris.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816589020212 [Primary]

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

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: 2018-03-29
• Device Publish Date: 2016-09-02

On-Brand Devices [AtamA™ System]

• 00816589020410: AtamA 2 Rolling Utility Stand
• 00816589020397: AtamA 2 Rolling Utility Stand
• 00816589020380: AtamA Patient Board
• 00816589020366: AtamA Patient Board
• 00816589020359: AtamA Head Fixation (3 piece)
• 00816589020342: AtamA Head Fixation (2 piece)
• 00816589020335: AtamA Patient Board
• 00816589020328: AtamA Patient Board
• 00816589020236: AtamA Head Fixation (2 piece)
• 00816589020229: AtamA Patient Board
• 00816589020212: AtamA Head Fixation (3 piece)
• 00816589020205: AtamA Patient Board
• 00816589020199: AtamA Patient Board
• 00816589020175: AtamA Patient Board
• 00816589020090: AtamA Patient Board