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Peerless Tpl 10ufm-10x22 0x18x45 Hklt
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 173-0423
Identity
- Trade Name
- PEERLESS TPL 10UFM-10X22 0X18X45 HKLT EUDAMEDPeerless Buccal Tube FDA UDI
- Generic Name
- Orthodontic tube FDA UDI
- Device Name
- PEERLESS TPL 10UFM-10X22 0X18X45 HKLT EUDAMEDFDA UDI
- Model / Reference
- 173-0423 EUDAMEDFDA UDI
- Description
- PEERLESS TPL 10UFM-10X22 0X18X45 HKLT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989021912 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00889989021912 EUDAMED
- FDA Product Code
- DZD FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS 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
Category: Orthodontic tube
Peerless Tpl 10ufm-10x22 0x18x45 Hklt by Ormco Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic tube.
- Master Series Bracket — American Orthodontics · Class IIa
- Metal brackets conventional milled — Bernhard Förster GmbH · Class IIa
- Ceramic brackets conventional — Bernhard Förster GmbH · Class IIa
- Metal bracket conventional — Bernhard Förster GmbH · Class IIa
- Master Series Bracket — American Orthodontics · Class IIa
- CASO KIRIONE ROTH .022 7X7 (3-4-5) C/10 — ID-LOGICAL INDUSTRIA E COMERCIO LTDA · Class IIa
- Metal Brackets — Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda · Class IIa
- V-Slot — ASTAR ORTHODONTICS INC. · Class IIa
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-00889989021912 | 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 a7b7e58b-aab8-4454-804c-0e98139a34de 61 fields · synced Aug 5, 2026
- FDA UDI 9be82181-34c2-43cf-9904-ce55ecb48dc8 35 fields · synced May 30, 2026