Identity
- Trade Name
- AURADONICS FDA UDI
- Generic Name
- Orthodontic separator FDA UDI
- Device Name
- SEPO II - LIGHT BLUE, 960 devices per package, see www.auradonics.com FDA UDI
- Model / Reference
- 500-004 FDA UDI
- Description
- SEPO II - LIGHT BLUE, 960 devices per package, see www.auradonics.com FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810033832116 FDA UDI
- FDA Product Code
- ECI FDA UDI
- GMDN Term
- Orthodontic separator 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic separator
Auradonics by Auradonics Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic separator.
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- The Orthodontic Store — Young Innovations, Inc. · Class I
- ELASTIC SEPARATORS — Ortho Organizers, Inc. · Class I
- Elastic Separator (80/pk) — SPECIALTY APPLIANCES, LLC · Class I
- ELASTIC SEPARATORS — Ortho Organizers, 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
- Auradonics Inc.
Sources (1)
- FDA UDI 223ce0e3-5e6b-4a32-8a23-69954fc35b21 35 fields · synced May 30, 2026