Midmark

Primary DI
00841709118234
Brand
Midmark
Company
MIDMARK CORPORATION
Model
M11-041 / 9A682001
Catalog number
M11-041-DL
Device description
The M11 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 Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority.
Published
2020-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLESterilizer, steam
OUGMedical device data system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLESterilizer, SteamGeneral Hospital2
OUGMedical Device Data SystemGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163337000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163337000Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic SterilizerMidmark Corporation2017-08-31FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841709118234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841709118234008417091182348417091182340841709118234

GMDN Terms#

Term, Definition table
TermDefinition
Steam sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, or steam. It typically includes a treatment chamber with shelves for device placement, and controls; it may be intended to sterilize wrapped and/or unwrapped devices. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)643-6275support@midmark.com

Regulatory Flags#

DUNS number
005036025
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841709124808Ritter228-001228-0012026-08-27
00841709124815Ritter228-002228-0022026-08-27
00841709124822Ritter228-003228-0032026-08-27
00841709124846Ritter229-002229-0022026-08-27
00841709124853Ritter229-003229-0032026-08-27
00841709109669Midmark626-005626-0052019-10-04
00841709109676Midmark626-006626-0062019-10-04
00841709105920Midmark626-001626-0012018-02-27
00841709105937Midmark626-002626-0022018-02-27
00841709105944Midmark626-003626-0032018-02-27
00841709105951Midmark626-004626-0042018-02-27
00841709105968Midmark627-011627-0112018-02-27
00841709105975Ritter225-002225-0022018-02-27
00841709105982Ritter225-003225-0032018-02-27
00841709105999Ritter224-001224-0012018-02-27
00841709106002Ritter224-002224-0022018-02-27
00841709106019Ritter224-003224-0032018-02-27
00841709106026Ritter224-011224-0112018-02-27
00841709105715MidmarkQC3R-01QC3R-012017-06-23
00841709105722MidmarkQC6R-01QC6R-012017-06-23

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Primary DI, Brand, Company table
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06945087500439EssilorSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.OUG2026-10-09
00724995364168AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
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