Midmark

FDA UDI

Class II (US FDA UDI)

by Midmark Corporation

Identity

Trade Name: Midmark FDA UDI
Generic Name: Steam sterilizer FDA UDI
Device Name: The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization. The Midmark printer is designed to record and print sterilization cycle data including time, chamber temperature, and pressure. FDA UDI
Model / Reference: M9-041 / 9A599001 FDA UDI
Description: The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization. The Midmark printer is designed to record and print sterilization cycle data including time, chamber temperature, and pressure. FDA UDI

Identifiers

Catalog Number: M11-041-P FDA UDI
Primary DI / UDI-DI: 00841709118180 FDA UDI
510(k) Number: K163337 FDA UDI
FDA Product Code: FLE FDA UDI
GMDN Term: Steam sterilizer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.6880 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

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Steam sterilizer Ink printer

Midmark by Midmark Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K163337 also covers:

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: Midmark Corporation

Sources (1)

FDA UDI 1e93f59c-a5cb-4720-898a-26e8cb62c227 36 fields · synced Jun 8, 2026