Identity
- Trade Name
- Panoramic FDA UDI
- Generic Name
- Radiological head/neck positioning mouthpiece FDA UDI
- Device Name
- Panoramic Disposable Positioning Bite Guides FDA UDI
- Model / Reference
- 50-02472X FDA UDI
- Description
- Panoramic Disposable Positioning Bite Guides FDA UDI
Identifiers
- Catalog Number
- 50-02472X FDA UDI
- Primary DI / UDI-DI
- 00840326416037 FDA UDI
- FDA Product Code
- IWY FDA UDI
- GMDN Term
- Radiological head/neck positioning mouthpiece FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1920 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
Yes
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
Panoramic by Young Innovations, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Young Innovations, Inc.
Sources (1)
- FDA UDI 93d6a5a0-dc27-4afc-b2e3-7e1e1268e831 35 fields · synced May 30, 2026