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Purple Tma Baf .016x.022 Up Sm Pk-5
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 210-4402
Identity
- Trade Name
- PURPLE TMA BAF .016X.022 UP SM PK-5 EUDAMEDTMA - Archwire FDA UDI
- Generic Name
- Orthodontic archwire FDA UDI
- Device Name
- PURPLE TMA BAF .016X.022 UP SM PK-5 EUDAMEDPURPLE TMA BAF 16X22 UP SM PK-5 FDA UDI
- Model / Reference
- 210-4402 EUDAMEDFDA UDI
- Description
- PURPLE TMA BAF 16X22 UP SM PK-5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989027679 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00889989027679 EUDAMED
- FDA Product Code
- DZC FDA UDI
- EMDN Code
- Q010405 ORTHODONTIC WIRES EUDAMED
- GMDN Term
- Orthodontic archwire 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
Purple Tma Baf .016x.022 Up Sm Pk-5 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-00889989027679 | 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 086cf880-5ed7-4a73-9904-6c0eb0571e00 61 fields · synced Oct 7, 2026
- FDA UDI ede5c3d5-b9e0-4e1b-9478-968f79e7dec1 35 fields · synced May 30, 2026