Identity
- Trade Name
- Medasil teeth protector FDA UDI
- Generic Name
- Mouthguard, single-use FDA UDI
- Device Name
- Sterile Silicone Bite Guards EUDAMEDsilicone non-sterile, 20 pieces/box FDA UDI
- Model / Reference
- 101-1120-1200 EUDAMED50-252-00 FDA UDI
- Description
- silicone non-sterile, 20 pieces/box FDA UDI
Identifiers
- Catalog Number
- 50-252-00 FDA UDI
- Primary DI / UDI-DI
- 05060465560056 EUDAMEDFDA UDI
- Basic UDI-DI
- 506046556101-11A6 EUDAMED
- Unit of Use DI
- 05060465560049 EUDAMED
- FDA Product Code
- BRW FDA UDI
- EMDN Code
- T0306 PATIENT PROTECTION DEVICES DURING CLINICAL PROCEDURES EUDAMED
- GMDN Term
- Mouthguard, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5820 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
Yes
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Radiation/mechanical corneal shield, reusable
Sterile Silicone Bite Guards by Medasil Surgical Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506046556101-11A6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medasil Surgical Limited
- EUDAMED SRN
- GB-MF-000009549
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (2)
- EUDAMED 6274c249-8ed3-43ba-9e81-d8e1e6e249d0 61 fields · synced Jul 24, 2026
- FDA UDI c3607aeb-62df-4601-a7a0-36ecd819aeac 35 fields · synced May 30, 2026