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 M11 Ultraclave 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. FDA UDI
Model / Reference: M11-040 FDA UDI
Description: The M11 Ultraclave 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. FDA UDI

Identifiers

Catalog Number: M11-040 FDA UDI
Primary DI / UDI-DI: 00841709100277 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

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

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

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PRIMUS Sterilizer — PRIMUS STERILIZER COMPANY, LLC. · Class II
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AG Neovo — ASSOCIATED INDUSTRIES CHINA, INC. · Class II

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 ef0898a3-a38d-4a1e-bc39-58d75aa3adad 37 fields · synced Jun 8, 2026