SureMAX

FDA UDI

Class II (US FDA UDI)

by Additive Implants, Inc.

Identity

Trade Name: SureMAX FDA UDI
Generic Name: Surgical mallet FDA UDI
Device Name: Cervical Mallet FDA UDI
Model / Reference: 1 FDA UDI
Description: Cervical Mallet FDA UDI

Identifiers

Primary DI / UDI-DI: 00817662024578 FDA UDI
FDA Product Code: KCT FDA UDI
GMDN Term: Surgical mallet FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.6850 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 194 Millimeter FDA UDI
Width — 50 Millimeter FDA UDI
Outer Diameter — 25.4 Millimeter FDA UDI

Category: Surgical mallet

SureMAX by Additive Implants, Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Additive Implants, Inc.

Sources (1)

FDA UDI f4c49796-0907-41e0-8b43-2fdc137906cc 35 fields · synced Jun 8, 2026