OraStretch® Press Device – Pediatric
GUDID 00850056079037
The OraStretch press system is indicated for individuals with, or at risk of trismus (limited oral opening) or jaw dysfunction. The appliance may also be used for physical therapy or rehabilitation of the mouth, jaw, or other orofacial tissues. The device is for single-patient use only. The Pediatric size is generally for patients under 10 years-old.
Cranio Mandibular Rehab, Inc.
Mastication muscle exerciser| Primary Device ID | 00850056079037 |
| NIH Device Record Key | 9fbf0728-5478-4c45-88e3-c17a99dbf5b3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OraStretch® Press Device – Pediatric |
| Version Model Number | CR1005 |
| 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 |
| support@craniorehab.com | |
| Phone | 1-800-206-8381 |
| support@craniorehab.com | |
| Phone | 1-800-206-8381 |
| support@craniorehab.com | |
| Phone | 1-800-206-8381 |
| support@craniorehab.com | |
| Phone | 1-800-206-8381 |
| support@craniorehab.com | |
| Phone | 1-800-206-8381 |
| support@craniorehab.com | |
| Phone | 1-800-206-8381 |
| support@craniorehab.com | |
| Phone | 1-800-206-8381 |
| support@craniorehab.com | |
| Phone | 1-800-206-8381 |
| support@craniorehab.com | |
| Phone | 1-800-206-8381 |
| support@craniorehab.com | |
| Phone | 1-800-206-8381 |
| support@craniorehab.com | |
| Phone | 1-800-206-8381 |
| support@craniorehab.com | |
| Phone | 1-800-206-8381 |
| support@craniorehab.com | |
| Phone | 1-800-206-8381 |
| support@craniorehab.com | |
| Phone | 1-800-206-8381 |
| support@craniorehab.com | |
| Phone | 1-800-206-8381 |
| support@craniorehab.com | |
| Phone | 1-800-206-8381 |
| support@craniorehab.com |
Device Dimensions
| Width | 45 Millimeter |
| Width | 45 Millimeter |
| Width | 45 Millimeter |
| Width | 45 Millimeter |
| Width | 45 Millimeter |
| Width | 45 Millimeter |
| Width | 45 Millimeter |
| Width | 45 Millimeter |
| Width | 45 Millimeter |
| Width | 45 Millimeter |
| Width | 45 Millimeter |
| Width | 45 Millimeter |
| Width | 45 Millimeter |
| Width | 45 Millimeter |
| Width | 45 Millimeter |
| Width | 45 Millimeter |
| Width | 45 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850056079037 [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 | 2023-10-13 |
| Device Publish Date | 2023-10-05 |
Devices Manufactured by Cranio Mandibular Rehab, Inc.
| 00850056079051 - 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 |
| 00850056079068 - 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 |
| 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. |
Trademark Results [OraStretch]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORASTRETCH 87216617 5333128 Live/Registered |
CranioMandibular Rehab, Inc. 2016-10-26 |
 ORASTRETCH 77522849 3671774 Dead/Cancelled |
CranioMandibular Rehab, Inc. 2008-07-15 |
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