Straight Wire

FDA UDI

Class I (US FDA UDI)

by Acme-Monaco Corp.

Identity

Trade Name: Straight Wire FDA UDI
Generic Name: Orthodontic archwire FDA UDI
Device Name: BETA-TITAN 17X25 14" PK10 FDA UDI
Model / Reference: 73-L002-1725 FDA UDI
Description: BETA-TITAN 17X25 14" PK10 FDA UDI

Identifiers

Primary DI / UDI-DI: D97273L00217252 FDA UDI
FDA Product Code: DZC FDA UDI
GMDN Term: Orthodontic archwire 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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthodontic archwire

Straight Wire by Acme-Monaco Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthodontic archwire.

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A.J. WILCOCK® TRUEFORM AUSTRALIAN WIRE SOLO-PACK — G&H Wire Company, Inc. · Class I
Masel — Ortho Organizers, Inc. · Class I
Stainless Steel Archwires — Ortho Organizers, Inc. · Class I
G4 EUROPA NICKEL TITANIUM — G&H Wire Company, 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: Acme-Monaco Corp.

Sources (1)

FDA UDI a2f6c394-f0a0-4563-b28b-704a3f7f5673 34 fields · synced Jun 20, 2026