OraMPA™ Microstomia Appliance - XL Semi-Circumferential

GUDID 00850056079402

The OraMPA™ Microstomia Appliance stretches the lips to prevent and treat microstomia. This version is for prevention.

Cranio Mandibular Rehab, Inc.

Mastication muscle exerciser

• Primary Device ID: 00850056079402
• NIH Device Record Key: bbe4a33a-ad8b-4348-9b43-c68e9f3f5edd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OraMPA™ Microstomia Appliance - XL Semi-Circumferential
• Version Model Number: CR1733
• Company DUNS: 048276773
• Company Name: Cranio Mandibular Rehab, 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-206-8381
• Email: support@craniorehab.com
• Phone: 1-800-206-8381
• Email: support@craniorehab.com
• Phone: 1-800-206-8381
• Email: support@craniorehab.com
• Phone: 1-800-206-8381
• Email: support@craniorehab.com
• Phone: 1-800-206-8381
• Email: support@craniorehab.com
• Phone: 1-800-206-8381
• Email: support@craniorehab.com
• Phone: 1-800-206-8381
• Email: support@craniorehab.com
• Phone: 1-800-206-8381
• Email: support@craniorehab.com
• Phone: 1-800-206-8381
• Email: support@craniorehab.com
• Phone: 1-800-206-8381
• Email: support@craniorehab.com
• Phone: 1-800-206-8381
• Email: support@craniorehab.com
• Phone: 1-800-206-8381
• Email: support@craniorehab.com
• Phone: 1-800-206-8381
• Email: support@craniorehab.com
• Phone: 1-800-206-8381
• Email: support@craniorehab.com
• Phone: 1-800-206-8381
• Email: support@craniorehab.com
• Phone: 1-800-206-8381
• Email: support@craniorehab.com
• Phone: 1-800-206-8381
• Email: support@craniorehab.com
• Phone: 1-800-206-8381
• Email: support@craniorehab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850056079402 [Primary]

FDA Product Code

• ION: Exerciser, Non-Measuring

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: 2024-04-09
• Device Publish Date: 2024-04-01

Devices Manufactured by Cranio Mandibular Rehab, Inc.

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• 00850056079075 - OraStretch® Bitepad Pack – Standard: 2024-04-09 The OraStretch Bitepads are self-adhesive pads used with the OraStretch press device to cushion the user's teeth. This pack inc
• 00850056079082 - OraStretch® Power Band Pack: 2024-04-09 The OraStretch Power Bands are used with a OraStretch press device to provide dynamic pressure of the device.
• 00850056079099 - OraStretch® Jaw ROM Scale Pack: 2024-04-09 The OraStretch Jaw ROM scales measure the opening and range-of-motion of the mouth.
• 00850056079105 - OraStretch® Deflection Deviation Scales: 2024-04-09 The OraStretch Deflection Deviation Scales measure the opening and range-of-motion of the mouth.
• 00850056079129 - OraStretch® Jaw MIO Plastic Scale: 2024-04-09 The OraStretch Jaw MIO scale measure the opening and range-of-motion of the mouth. It is a single-patient plastic version of th
• 00850056079136 - OraMPA™ Microstomia Appliance: 2024-04-09 The OraMPA™ Microstomia Appliance stretches the lips to prevent and treat microstomia.