Identity
- Trade Name
- TruGuard™ FDA UDI
- Generic Name
- Radiological head/neck positioning mouthpiece FDA UDI
- Device Name
- TruGuard, Standard FDA UDI
- Model / Reference
- HNRT-3501 FDA UDI
- Description
- TruGuard, Standard FDA UDI
Identifiers
- Catalog Number
- HNRT-3501 FDA UDI
- Primary DI / UDI-DI
- 00714646000415 FDA UDI
- 510(k) Number
- K153270 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Radiological head/neck positioning mouthpiece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 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
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
Yes
FDA UDI
Category: Radiological head/neck positioning mouthpiece
TruGuard™ by Bionix, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Precise Bite™ — Medtec LLC · Class II
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 |
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Manufacturer
- Manufacturer
- Bionix, LLC
Sources (1)
- FDA UDI 5ce3aa61-11f0-45e8-906a-a9fb2fbc60c4 36 fields · synced May 29, 2026