Identity
- Trade Name
- RMO FDA UDI
- Generic Name
- Self-ligating orthodontic bracket open/close tool FDA UDI
- Device Name
- FLI SL 3.0 INSTRUMENT FDA UDI
- Model / Reference
- I00040 FDA UDI
- Description
- FLI SL 3.0 INSTRUMENT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00885797545701 FDA UDI
- FDA Product Code
- DZN FDA UDI
- GMDN Term
- Self-ligating orthodontic bracket open/close tool FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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: Self-ligating orthodontic bracket open/close tool
Rmo by Rmo — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Self-ligating orthodontic bracket open/close tool.
- InBrace Starter Kit — SWIFT HEALTH SYSTEMS INC. · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- J&J Instruments — J&J Instruments, LLC · Class I
- J&J Instruments — J&J Instruments, LLC · Class I
- Two pronged probe for BioQuick Brackets — Forestadent Bernhard Förster GmbH · Class I
- CARRIERE SLX 3D — Ortho Organizers, Inc. · Class I
- CARRIERE SLX 3D — Ortho Organizers, Inc. · Class I
- Twin Force® Locking Tool — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Rmo
Sources (1)
- FDA UDI 649e1682-8cec-4d11-b8f5-aef8f48fdbb9 33 fields · synced May 31, 2026