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M3 Printer

FDA UDI

Class II (US FDA UDI)

by Midmark Corporation

Identity

Trade Name
M3 Printer FDA UDI
Generic Name
Ink printer FDA UDI
Device Name
The M9 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
9A401001 FDA UDI
Description
The M9 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
9A401001 FDA UDI
Primary DI / UDI-DI
00841709100192 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ink printer

M3 Printer by Midmark Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ink printer.

Cleared under the same submission

K090670 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Midmark Corporation

Sources (1)

  • FDA UDI 9b94a499-c53a-4d8f-87e3-70f989415997 36 fields · synced Jun 8, 2026