FDA UDI
In Commercial Distribution
🇺🇸 United States
OraStretch® Press Device – Anterior
DI: 00850056079020
·
Model: CR1003
·
Cranio Mandibular Rehab, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OraStretch® Press Device – Anterior
- Primary DI
- 00850056079020
- Version / Model
- CR1003
- Company Name
- Cranio Mandibular Rehab, Inc.
- Labeler DUNS
- 048276773
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-05
- Public Version
- 1
- Public Version Date
- 2023-10-13
- Public Version Status
- New
- Public Device Record Key
- 265d1b76-d1c4-4a03-8572-2a66de6cade0
Device Description
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 Anterior size has a mouthpiece that only contacts the anterior teeth.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ION | Exerciser, Non-Measuring | Physical Medicine | 890.5370 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17802 | Mastication muscle exerciser | An intraoral mechanical exercise apparatus intended primarily to strengthen and rehabilitate the jaw muscles of mastication of a patient who has pain in, or disorders of, the temporomandibular joint (TMJ), typically through repetitive biting against resistive forces provided by the device. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850056079020 | GS1 |
Customer Contacts
- Phone
- 1-800-206-8381
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 60 | Millimeter |