Identity
- Trade Name
- OraStretch® Press Device – Standard FDA UDI
- Generic Name
- Mastication muscle exerciser FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- CR1000 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850056079006 FDA UDI
- FDA Product Code
- ION FDA UDI
- GMDN Term
- Mastication muscle exerciser FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 60 Millimeter FDA UDI
Category: Mastication muscle exerciser
OraStretch® Press Device – Standard by CranioMandibular Rehab, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- CranioMandibular Rehab, Inc.
Sources (1)
- FDA UDI 61ddb402-96f1-4028-bf77-0b35160fd484 35 fields · synced Jun 9, 2026