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Ad Prot. Facemask Blue - International
EUDAMEDFDA UDIClass I (EU MDR)
Ref 716-1050Model 716-*
Identity
- Trade Name
- AD PROT. FACEMASK BLUE - INTERNATIONAL EUDAMEDA.D. Protraction FDA UDI
- Generic Name
- Orthodontic extraoral headgear FDA UDI
- Device Name
- FACEMASK EUDAMEDInternational Face Mask Blue FDA UDI
- Model / Reference
- 716-* EUDAMED716-1050 EUDAMEDFDA UDI
- Description
- International Face Mask Blue FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989060003 EUDAMEDFDA UDI
- Basic UDI-DI
- 0889989-ExOrl_Facemask-9W EUDAMED
- FDA Product Code
- DZB FDA UDI
- EMDN Code
- Q010401 ORTHODONTIC FACE BOWS EUDAMED
- GMDN Term
- Orthodontic extraoral headgear FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.5500 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Ad Prot. Facemask Blue - International by Ormco Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0889989-ExOrl_Facemask-9W | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ormco Corporation
- EUDAMED SRN
- US-MF-000038085
- Authorised Representative
- KERR ITALIA SRL IT-AR-000007600
Sources (2)
- EUDAMED 39521bf1-5699-49ec-8b8d-d28ad338ef39 61 fields · synced Jul 11, 2026
- FDA UDI 3b1326e3-31a5-49b6-97f1-06f20655db5d 34 fields · synced May 30, 2026