Primary Device ID | 00850056079020 |
NIH Device Record Key | 265d1b76-d1c4-4a03-8572-2a66de6cade0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OraStretch® Press Device – Anterior |
Version Model Number | CR1003 |
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 |
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 |
Width | 60 Millimeter |
Width | 60 Millimeter |
Width | 60 Millimeter |
Width | 60 Millimeter |
Width | 60 Millimeter |
Width | 60 Millimeter |
Width | 60 Millimeter |
Width | 60 Millimeter |
Width | 60 Millimeter |
Width | 60 Millimeter |
Width | 60 Millimeter |
Width | 60 Millimeter |
Width | 60 Millimeter |
Width | 60 Millimeter |
Width | 60 Millimeter |
Width | 60 Millimeter |
Width | 60 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850056079020 [Primary] |
ION | Exerciser, Non-Measuring |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-10-13 |
Device Publish Date | 2023-10-05 |
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. |
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 |