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Orthos Cm B/T Lfm Odbl -10x022 Rt
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 342-0046
Identity
- Trade Name
- Peerless Buccal Tube FDA UDI
- Generic Name
- Orthodontic tube FDA UDI
- Device Name
- ORTHOS CM B/T LFM ODBL -10X022 RT EUDAMEDFDA UDI
- Model / Reference
- 342-0046 EUDAMEDFDA UDI
- Description
- ORTHOS CM B/T LFM ODBL -10X022 RT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989015294 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00889989015294 EUDAMED
- FDA Product Code
- DZD FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic tube FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.5410 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Orthos Cm B/T Lfm Odbl -10x022 Rt 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-00889989015294 | 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 5fd83cc8-c439-4f1f-86a1-a58380542778 61 fields · synced Jul 23, 2026
- FDA UDI b29385bb-cb2f-44ba-92ab-518fb9fc3e8b 35 fields · synced May 30, 2026