Crimpable Spacer for TS, 3mm, Pk/2

FDA UDI

Class I (US FDA UDI)

by Allesee Aoa-Pro

Identity

Trade Name: Crimpable Spacer for TS, 3mm, Pk/2 FDA UDI
Generic Name: Orthodontic clasp, metal, custom-made FDA UDI
Device Name: Crimpable Spacer for TS, 3mm, Pk/2 FDA UDI
Model / Reference: MATER128C FDA UDI
Description: Crimpable Spacer for TS, 3mm, Pk/2 FDA UDI

Identifiers

Primary DI / UDI-DI: 00889989087581 FDA UDI
FDA Product Code: EJF FDA UDI
GMDN Term: Orthodontic clasp, metal, custom-made 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

Yes

FDA UDI

Category: Orthodontic clasp, metal, custom-made

Crimpable Spacer for TS, 3mm, Pk/2 by Allesee Aoa-Pro — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Allesee Aoa-Pro

Sources (1)

FDA UDI 4117e77c-6a70-4ff7-8805-251657a5c117 34 fields · synced Jun 1, 2026