FDA.reportPublic FDA data

M11 Horizontal Cassette Rack

Primary DI
00841709100178
Brand
M11 Horizontal Cassette Rack
Company
MIDMARK CORPORATION
Model
9A215001
Catalog number
9A215001
Device description
The M11 horizontal cassette rack holds four large and for small cassettes
Published
2016-09-23
Public version status
Update
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
K990189000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990189000MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZERMidmark Corp.1999-04-19FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841709100178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841709100178008417091001788417091001780841709100178

GMDN Terms#

Term, Definition table
TermDefinition
Sterilizer/disinfector rackA non-sterile rack or group of shelves intended to hold medical devices in a sterilizer or chemical washer/disinfector during the sterilization or washing/disinfection cycle. It may also be used to transport medical devices to and from the process and for their temporary storage. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
005036025
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00841709110030Midmark153678CM153678CM2026-09-28
00841709110054Midmark153678WL153678WL2026-09-28
00841709110061Midmark153678WS153678WS2026-09-28
00841709111846Midmark153600-001153600-0012026-09-28
00841709111853Midmark153600-002153600-0022026-09-28
00841709110337Midmark153603LR-E153603LR-E2020-05-22
00841709110344Midmark153604CE153604CE2020-05-22
00841709110375Midmark153604LRCA-E153604LRCA-E2020-05-22
00841709110382Midmark153604LR-E153604LR-E2020-05-22
00841709111839Midmark153603C153603C2020-05-22
00841709108907Midmark153592-002153592-0022020-10-30

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07640397422325BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07629999282957Enbio-Autoclave Control FirmwareEnbio Group AGFLE2026-03-02
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06972615108003icanclaveNingbo Ican Machines Co., Ltd.FLE2025-12-19
05904165664280EnbioENBIO TECHNOLOGY SP Z O OFLE2025-10-28
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06971608311505ADSGuangzhou Ajax Medical Equipment Co., Ltd.FLE2025-09-15
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