FDA.reportPublic FDA data

Midmark

Primary DI
00841709118173
Brand
Midmark
Company
MIDMARK CORPORATION
Model
M9-040 / 9A599001
Catalog number
M9-040-P
Device description
The M9 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 printer is designed to record and print sterilization cycle data including time, chamber temperature, and pressure.
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLESterilizer, SteamGeneral Hospital2

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
00841709118173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841709118173008417091181738417091181730841709118173

GMDN Terms#

Term, Definition table
TermDefinition
Ink printerA colour or monochrome printer designed to propel droplets of ink directly onto a medium (typically paper) to produce a printed image.

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
00841709105715MidmarkQC3R-01QC3R-012017-06-23
00841709105722MidmarkQC6R-01QC6R-012017-06-23
00841709112577MidmarkDCV5-G2X/HDCV5-G2X/H2021-01-15
00841709112713MidmarkDCV6-G2X/HDCV6-G2X/H2021-01-15
00841709112850MidmarkDCV7-G2X/HDCV7-G2X/H2021-01-15
00841709112928MidmarkDCV8-G2X/HDCV8-G2X/H2021-01-15
00841709112997MidmarkDCVM-G0X/HDCVM-G0X/H2021-01-15
00841709103551MidmarkP7015V-PP7015V-P2017-02-16
00841709103575MidmarkP7016V-PP7016V-P2017-02-16
00841709103599MidmarkP7017V-PP7017V-P2017-02-16
00841709103605MidmarkP7018V-PP7018V-P2017-02-16
00841709108860Midmark153810-001153810-0012026-09-29
00841709108877Midmark153810-002153810-0022026-09-29
00841709108884Midmark153810-003153810-0032026-09-29
00841709109805Midmark153600-020153600-0202026-09-28
00841709109812Midmark153600-021153600-0212026-09-28
00841709109843Midmark153600-304153600-3042026-09-28
00841709109850Midmark153600-305153600-3052026-09-28
00841709109874Midmark153600-504153600-5042026-09-28
00841709109881Midmark153600-505153600-5052026-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00724995364205AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364212AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364229AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364236AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364243AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364250AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
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