Midmark

FDA UDI

Class II (US FDA UDI)

by Midmark Corporation

Identity

Trade Name: Midmark FDA UDI
Generic Name: Ink printer FDA UDI
Device Name: The M3 printer is optimal for mechanical monitoring of each cycle. Records and prints critical sterilization cycle data, including chamber temperature and pressure, cycle elapsed times, and program cycle type. FDA UDI
Model / Reference: 9A401002 FDA UDI
Description: The M3 printer is optimal for mechanical monitoring of each cycle. Records and prints critical sterilization cycle data, including chamber temperature and pressure, cycle elapsed times, and program cycle type. FDA UDI

Identifiers

Catalog Number: 9A401002 FDA UDI
Primary DI / UDI-DI: 00841709109591 FDA UDI
510(k) Number: K090670 FDA UDI
FDA Product Code: FLE FDA UDI
GMDN Term: Ink printer 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: 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

K090670 also covers:

M3 Printer — Midmark Corporation
M3 UltraFast — Midmark Corporation
M3 Ultrafast — Midmark Corporation
Midmark — Midmark Corporation
Midmark — Midmark Corporation
Midmark — Midmark Corporation
Ritter M3 UltraFast — Midmark Corporation
Ritter M3 UltraFast — Midmark Corporation

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 2a76f797-3019-43b8-bc40-b67cf8037fd9 36 fields · synced Jun 8, 2026