Orthomed

FDA UDI

Class I (US FDA UDI)

by Ortho-Med, Inc.

Identity

Trade Name: ORTHOMED FDA UDI
Generic Name: Surgical mallet FDA UDI
Device Name: LUCAE BONE MALLET WEIGHT: 9 OZ/5 OZ FDA UDI
Model / Reference: OM 46-0660 FDA UDI
Description: LUCAE BONE MALLET WEIGHT: 9 OZ/5 OZ FDA UDI

Identifiers

Primary DI / UDI-DI: B8034606600 FDA UDI
FDA Product Code: GFJ FDA UDI
GMDN Term: Surgical mallet FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical mallet

A comprehensive hand-held surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. This is a reusable device.

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Also classified as Surgical mallet.

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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: Ortho-Med, Inc.

Sources (1)

FDA UDI 8f25a1c1-9e21-485a-bda8-e4a936affd65 33 fields · synced Jul 24, 2026