Main-Mallet-Spinal Simplicity

FDA UDI

Class I (US FDA UDI)

by Mainstream Medical Devices

Identity

Trade Name: Main-Mallet-Spinal Simplicity FDA UDI
Generic Name: Surgical mallet FDA UDI
Device Name: Single-Use, Surgical Mallet, Slotted, 8" Small Contoured Handle, 16oz Head Weight, Spinal Simplicity, Sterile FDA UDI
Model / Reference: 316-35-911 FDA UDI
Description: Single-Use, Surgical Mallet, Slotted, 8" Small Contoured Handle, 16oz Head Weight, Spinal Simplicity, Sterile FDA UDI

Identifiers

Catalog Number: 35-0011-000 FDA UDI
Primary DI / UDI-DI: B908350011000 FDA UDI
FDA Product Code: HXL 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

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Weight — 1 Pound FDA UDI
Length — 8 Inch FDA UDI

Category: Surgical mallet

Main-Mallet-Spinal Simplicity by Mainstream Medical Devices — 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: Mainstream Medical Devices

Sources (1)

FDA UDI aadb433c-8229-41e0-923e-8d7e7350ac45 36 fields · synced Jun 8, 2026