Identity
- Trade Name
- Pinnacle Temple Guard FDA UDI
- Generic Name
- Headrest cover FDA UDI
- Device Name
- Panoramic HeadPositioning Guide Cover FDA UDI
- Model / Reference
- 7300C FDA UDI
- Description
- Panoramic HeadPositioning Guide Cover FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00615375004715 FDA UDI
- FDA Product Code
- MMP FDA UDI
- GMDN Term
- Headrest cover FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Headrest cover
Pinnacle Temple Guard by Metrex Research — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Headrest cover.
- Pinnacle Chin Guard — METREX RESEARCH · Class II
- Pinnacle Headrest Cover — METREX RESEARCH · Class II
- Allrap Protective Barriers — METREX RESEARCH · Class I
- Pinnacle Headrest Cover — METREX RESEARCH · Class II
- Allrap Protective Barriers — METREX RESEARCH · Class I
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Metrex Research
Sources (1)
- FDA UDI c5742b47-3756-4456-9027-d05388613fa7 34 fields · synced May 30, 2026