Identity
- Trade Name
- Amazon Basics FDA UDI
- Generic Name
- Mouthguard, reusable FDA UDI
- Device Name
- Grind No More Classic Dental Guard 2 Dental Guards, Storage Case and Fitting Tray SQN5485C1 FDA UDI
- Model / Reference
- SQN54 FDA UDI
- Description
- Grind No More Classic Dental Guard 2 Dental Guards, Storage Case and Fitting Tray SQN5485C1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195515045247 FDA UDI
- FDA Product Code
- OBR FDA UDI
- GMDN Term
- Mouthguard, reusable FDA UDI
Classification
- Device Class
- U 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Mouthguard, reusable
Amazon Basics by Amazon.com Services, LLC — Class U — 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 U | Pending data |
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Manufacturer
- Manufacturer
- Amazon.com Services, LLC
Sources (1)
- FDA UDI c2229738-58ee-4f83-a998-416c0b33665d 33 fields · synced Jun 1, 2026