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M11 Horizontal Cassette Rack

FDA UDI

Class II (US FDA UDI)

by Midmark Corporation

Identity

Trade Name
M11 Horizontal Cassette Rack FDA UDI
Generic Name
Sterilizer/disinfector rack FDA UDI
Device Name
The M11 horizontal cassette rack holds four large and for small cassettes FDA UDI
Model / Reference
9A215001 FDA UDI
Description
The M11 horizontal cassette rack holds four large and for small cassettes FDA UDI

Identifiers

Catalog Number
9A215001 FDA UDI
Primary DI / UDI-DI
00841709100178 FDA UDI
510(k) Number
K990189 FDA UDI
FDA Product Code
FLE FDA UDI
GMDN Term
Sterilizer/disinfector rack 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Sterilizer/disinfector rack

M11 Horizontal Cassette Rack by Midmark Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sterilizer/disinfector rack.

Cleared under the same submission

K990189 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 72be4504-4603-4151-9222-da20525b5352 36 fields · synced Jun 8, 2026