Eclipse Interactive

FDA UDI

Class I (US FDA UDI)

by Ortho Arch Company Inc

Identity

Trade Name: ECLIPSE INTERACTIVE FDA UDI
Generic Name: Self-ligating orthodontic bracket FDA UDI
Device Name: 018 U1L ECLIPSE INTERACTIVE SLB MBT +17T (5) FDA UDI
Model / Reference: 461-602 FDA UDI
Description: 018 U1L ECLIPSE INTERACTIVE SLB MBT +17T (5) FDA UDI

Identifiers

Catalog Number: 461-602 FDA UDI
Primary DI / UDI-DI: D90946160216 FDA UDI
FDA Product Code: ECI FDA UDI
GMDN Term: Self-ligating orthodontic bracket 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Self-ligating orthodontic bracket

Eclipse Interactive by Ortho Arch Company Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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VAR-22-301 — GNI Co., Ltd · Class II
VAM-18-553 — GNI Co., Ltd · Class II

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 Arch Company Inc

Sources (1)

FDA UDI 3c030343-0ccc-41c4-8759-1d3e1111084f 34 fields · synced Jun 8, 2026