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Ligature

FDA UDI

Class I (US FDA UDI)

by Acme-Monaco Corp.

Identity

Trade Name
Ligature FDA UDI
Generic Name
Orthodontic archwire FDA UDI
Device Name
012 SHORT TWISTED LIGATURE WHITE FDA UDI
Model / Reference
AMC12WTWLIG FDA UDI
Description
012 SHORT TWISTED LIGATURE WHITE FDA UDI

Identifiers

Primary DI / UDI-DI
D972AMC12WTWLIG6 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

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthodontic archwire

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

Similar devices

Also classified as Orthodontic archwire.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Acme-Monaco Corp.

Sources (1)

  • FDA UDI 9808578d-774e-4dee-943a-92e24cca6651 34 fields · synced Jun 20, 2026