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Facebow S/R Super Short Szlg .044 Dia
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 200-0268
Identity
- Trade Name
- SR Facebow FDA UDI
- Generic Name
- Orthodontic face bow FDA UDI
- Device Name
- FACEBOW S/R SUPER SHORT SZLG .044 DIA EUDAMEDFacebow SUPER SHORT SZ LG .044 DIA FDA UDI
- Model / Reference
- 200-0268 EUDAMEDFDA UDI
- Description
- Facebow SUPER SHORT SZ LG .044 DIA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989023466 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00889989023466 EUDAMED
- FDA Product Code
- DZB FDA UDI
- EMDN Code
- Q010401 ORTHODONTIC FACE BOWS EUDAMED
- GMDN Term
- Orthodontic face bow FDA UDI
Classification
- Device Class
- Class IIa 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
Facebow S/R Super Short Szlg .044 Dia by Ormco Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00889989023466 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 f47e2249-1135-4952-92b4-cda7e4c44bb2 61 fields · synced Jun 17, 2026
- FDA UDI 69c5f97e-baae-445a-ad74-bc09481579b2 35 fields · synced May 26, 2026