Identity
- Trade Name
- Tru-Chrome FDA UDI
- Generic Name
- Orthodontic wire FDA UDI
- Device Name
- FLEX-VIII ARCH 018X025 PKG10 FDA UDI
- Model / Reference
- E01404 FDA UDI
- Description
- FLEX-VIII ARCH 018X025 PKG10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00885797020208 FDA UDI
- FDA Product Code
- DZC FDA UDI
- GMDN Term
- Orthodontic wire 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 wire
Tru-Chrome by Rmo — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic wire.
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- Noninium® — Dentaurum · Class I
- Reflex Nickel Titanium Wire — TP ORTHODONTICS, INC. · Class I
- Pg Supply — Pg Supply, Inc. · Class I
- ORTHOSOURCE — Ortho Source · 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
- Rmo
Sources (1)
- FDA UDI 4f0610f2-c0e8-4b05-956d-1c99d82c218b 33 fields · synced May 31, 2026