Identity
- Trade Name
- Elastic Separator (80/pk) FDA UDI
- Generic Name
- Orthodontic separator FDA UDI
- Model / Reference
- 900163 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D8199001630 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic separator
Elastic Separator (80/pk) by Specialty Appliances, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic separator.
- ELASTIC SEPARATORS — Ortho Organizers, Inc. · Class I
- Sep-A-Rings Separators — TP ORTHODONTICS, INC. · Class I
- AURADONICS — AURADONICS INC. · Class I
- Sep-A-Rings Separators — TP ORTHODONTICS, INC. · Class I
- AURADONICS — AURADONICS INC. · Class I
- The Orthodontic Store — Young Innovations, Inc. · Class I
- ELASTIC SEPARATORS — Ortho Organizers, Inc. · Class I
- AURADONICS — AURADONICS 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
- Specialty Appliances, Llc
Sources (1)
- FDA UDI 80c2386a-0799-4d2c-a443-dcd3ddd143b1 32 fields · synced Jun 1, 2026