Identity
- Trade Name
- M1E-18-031 FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Model / Reference
- M1E-18-031 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800046006538 FDA UDI
- FDA Product Code
- EJF FDA UDI
- GMDN Term
- Orthodontic bracket, metal 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
No
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
No
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 bracket, metal
M1e-18-031 by GNI Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic bracket, metal.
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- MIRABAY — MIRABAY ORTHODONTICS CORPORATION · Class I
- RMO — RMO · Class I
- Mini-Mono® — Forestadent Bernhard Förster GmbH · Class I
- Votion — ORTHO TECHNOLOGY, INC. · Class I
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
- Manufacturer
- GNI Co., Ltd
Sources (1)
- FDA UDI 4917661b-b0f6-444b-a663-fb268b2f4c5d 32 fields · synced Jun 1, 2026