| Primary Device ID | 00850056079075 |
| NIH Device Record Key | b1cde432-fda3-43b1-b711-e8f4b212213b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OraStretch® Bitepad Pack – Standard |
| Version Model Number | CR1057 |
| 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 | |
| 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 |
| Width | 60 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850056079075 [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 | 2024-04-09 |
| Device Publish Date | 2024-04-01 |
| 00850056079075 | The OraStretch Bitepads are self-adhesive pads used with the OraStretch press device to cushion |
| 00850056079068 | The OraStretch Bitepads are self-adhesive pads used with the OraStretch press device to cushion |
| 00850056079051 | The OraStretch Bitepads are self-adhesive pads used with the OraStretch press device to cushion |
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 |