Identity
- Trade Name
- MIRABAY FDA UDI
- Generic Name
- Orthodontic spring FDA UDI
- Device Name
- DISTALIZING SPRING NITI 0.011 X 0.045 7IN PK3 FDA UDI
- Model / Reference
- 631-0010 FDA UDI
- Description
- DISTALIZING SPRING NITI 0.011 X 0.045 7IN PK3 FDA UDI
Identifiers
- Catalog Number
- 631-0010 FDA UDI
- Primary DI / UDI-DI
- 05061075022224 FDA UDI
- FDA Product Code
- ECO FDA UDI
- GMDN Term
- Orthodontic spring 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
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 spring
Mirabay by Mirabay Orthodontics Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic spring.
- Original Side-Winder Uprighting Spring — TP ORTHODONTICS, INC. · Class I
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- RMO — RMO · Class I
- Stainless Steel Closed Coil Spring — ORTHO ARCH COMPANY INC · Class I
- Orthodontic Spring — DENTOS Inc. · Class I
- OSE — ORTHODONTIC SUPPLY & EQUIPMENT CO., INC. · Class I
- Begg Spring-Pin — TP ORTHODONTICS, INC. · Class I
- Ortho Organizers — Ortho Organizers, 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
- Mirabay Orthodontics Corporation
Sources (1)
- FDA UDI 335e31f3-fc07-4c29-90d0-ba6ea108e338 35 fields · synced May 30, 2026