Mouth spacer MZ/602

GUDID 03660381013753

MEDICAL Z

Microstomia splinting appliance

• Primary Device ID: 03660381013753
• NIH Device Record Key: 663aef31-5370-4982-9458-0a4ce2b09108
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mouth spacer
• Version Model Number: BS802-000SM-000
• Catalog Number: MZ/602
• Company DUNS: 273431759
• Company Name: MEDICAL Z
• 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: false
• Manufacturing Date: false
• 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: +1(832)767-5978
• Email: s.malbrel@medicalz.com
• Phone: +1(832)767-5978
• Email: s.malbrel@medicalz.com
• Phone: +1(832)767-5978
• Email: s.malbrel@medicalz.com
• Phone: +1(832)767-5978
• Email: s.malbrel@medicalz.com
• Phone: +1(832)767-5978
• Email: s.malbrel@medicalz.com
• Phone: +1(832)767-5978
• Email: s.malbrel@medicalz.com
• Phone: +1(832)767-5978
• Email: s.malbrel@medicalz.com
• Phone: +1(832)767-5978
• Email: s.malbrel@medicalz.com
• Phone: +1(832)767-5978
• Email: s.malbrel@medicalz.com
• Phone: +1(832)767-5978
• Email: s.malbrel@medicalz.com
• Phone: +1(832)767-5978
• Email: s.malbrel@medicalz.com
• Phone: +1(832)767-5978
• Email: s.malbrel@medicalz.com
• Phone: +1(832)767-5978
• Email: s.malbrel@medicalz.com
• Phone: +1(832)767-5978
• Email: s.malbrel@medicalz.com
• Phone: +1(832)767-5978
• Email: s.malbrel@medicalz.com
• Phone: +1(832)767-5978
• Email: s.malbrel@medicalz.com
• Phone: +1(832)767-5978
• Email: s.malbrel@medicalz.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03660381013753 [Primary]

FDA Product Code

• MDA: Elastomer, silicone, for scar management

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: 2024-04-24
• Device Publish Date: 2024-04-16

Devices Manufactured by MEDICAL Z

• 03660381001460 - Mammostat: 2024-06-17
• 03660381013753 - Mouth spacer: 2024-04-24
• 03660381013753 - Mouth spacer: 2024-04-24