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Rex Mallet

FDA UDI

Class I (US FDA UDI)

by Rex Implants, Inc

Identity

Trade Name
Rex Mallet FDA UDI
Generic Name
Orthopaedic implant impactor, reusable FDA UDI
Device Name
Crown Remover FDA UDI
Model / Reference
Crown Remover FDA UDI
Description
Crown Remover FDA UDI

Identifiers

Catalog Number
04570011-101 FDA UDI
Primary DI / UDI-DI
D894045700111010 FDA UDI
FDA Product Code
GEY FDA UDI
GMDN Term
Orthopaedic implant impactor, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4820 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic implant impactor, reusable

Rex Mallet by Rex Implants, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic implant impactor, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rex Implants, Inc

Sources (1)

  • FDA UDI a9f0faa8-d16e-4fb2-ac8e-1e766dcdec38 36 fields · synced May 30, 2026