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Premium Elite Kit Roth 0.022 – 1 Set + 4 Tubes + 1 Pair Of Arches + 1 Modular
FDA UDIClass I (US FDA UDI)
by Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda
Identity
- Trade Name
- PREMIUM ELITE KIT ROTH 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULAR FDA UDI
- Generic Name
- Orthodontic tube FDA UDI
- Device Name
- PREMIUM ELITE KIT ROTH 0.022 – 1 SET 4 TUBES 1 PAIR OF ARCHEWIRE 1 MODULAR LIGATURE FDA UDI
- Model / Reference
- 11.20.2913 FDA UDI
- Description
- PREMIUM ELITE KIT ROTH 0.022 – 1 SET 4 TUBES 1 PAIR OF ARCHEWIRE 1 MODULAR LIGATURE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07908611211163 FDA UDI
- FDA Product Code
- DZD FDA UDIDZC FDA UDIECI FDA UDIEJF FDA UDI
- GMDN Term
- Orthodontic tube FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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 tubeOrthodontic archwireOrthodontic bracket, metalOrthodontic inter-arch elastic band
Premium Elite Kit Roth 0.022 – 1 Set + 4 Tubes + 1 Pair Of Arches + 1 Modular by Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda…
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
Sources (1)
- FDA UDI 3f0abebe-c2e6-45c3-9991-b108390ce0ef 33 fields · synced May 30, 2026