Identity
- Trade Name
- Ortho Traction Pads FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- Round Pad Eyelet Profile XL Chain - RPEP XL FDA UDI
- Model / Reference
- RPEP XL FDA UDI
- Description
- Round Pad Eyelet Profile XL Chain - RPEP XL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850038184124 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dry Heat Sterilization FDA UDI
Category: Orthodontic bracket, metal
Ortho Traction Pads by Ortho Traction Pads — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic bracket, metal.
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- 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
- Ortho Traction Pads
Sources (1)
- FDA UDI 64289fda-84cb-40f9-8c5e-fa67088e9d97 33 fields · synced May 30, 2026