Ritter M9-042-P

GUDID 00841709118197

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.

MIDMARK CORPORATION

Steam sterilizer

• Primary Device ID: 00841709118197
• NIH Device Record Key: 308c4edc-3104-4eb3-ae09-455be7b301a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ritter
• Version Model Number: M9-042 / 9A599001
• Catalog Number: M9-042-P
• Company DUNS: 005036025
• Company Name: MIDMARK CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(800)643-6275
• Email: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841709118197 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163337

FDA Product Code

• FLE: Sterilizer, steam

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-05
• Device Publish Date: 2020-07-28

On-Brand Devices [Ritter]

• 00192965000000: Not Required
• 00841709109423: This power procedures table is intended to be used as a chair / table to provide positioning and
• 00841709109096: The 203 Treatment Table is constructed of steel from its frame to its legs, and its flat top is
• 00841709109089: The 203 Treatment Table is constructed of steel from its frame to its legs, and its flat top is
• 00841709109072: The 203 Treatment Table is constructed of steel from its frame to its legs, and its flat top is
• 00841709109065: The 203 Treatment Table is constructed of steel from its frame to its legs, and its flat top is
• 00841709109058: The 203 Treatment Table is constructed of steel from its frame to its legs, and its flat top is
• 00841709109041: The 203 Treatment Table is constructed of steel from its frame to its legs, and its flat top is
• 00841709109034: The 203 Treatment Table is constructed of steel from its frame to its legs, and its flat top is
• 00841709109027: The 203 Treatment Table is constructed of steel from its frame to its legs, and its flat top is
• 00841709106798: The Ritter Mobile (without power cord) LED Procedure Light is intended to be used in medical env
• 00841709106781: The Ritter Wall Mount LED Procedure Light is intended to be used in medical environments where i
• 00841709106774: The Ritter Mobile LED Procedure Light is intended to be used in medical environments where illum
• 00841709106767: The Ritter 9' Dual Ceiling Mount LED Procedure Light is intended to be used in medical environme
• 00841709106750: The Ritter 8' Dual Ceiling Mount LED Procedure Light is intended to be used in medical environme
• 00841709106743: The Ritter 9' Single Ceiling Mount LED Procedure Light is intended to be used in medical environ
• 00841709106736: The Ritter 8' Single Ceiling Mount LED Procedure Light is intended to be used in medical environ
• 00841709106453: This power procedures table is intended to be used as a chair / table to provide positioning and
• 00841709106446: This power procedures table is intended to be used as a chair / table to provide positioning and
• 00841709106439: This power procedures table is intended to be used as a chair / table to provide positioning and
• 00841709106354: The Ritter 253 LED Exam Light provides focusable illumination for general examinations and proce
• 00841709106347: The Ritter 253 LED Exam Light provides focusable illumination for general examinations and proce
• 00841709106330: The Ritter 253 LED Exam Light provides focusable illumination for general examinations and proce
• 00841709106323: The Ritter 253 LED Exam Light provides focusable illumination for general examinations and proce
• 00841709106316: The Ritter 253 LED Exam Light provides focusable illumination for general examinations and proce
• 00841709106309: The Ritter 253 LED Exam Light provides focusable illumination for general examinations and proce
• 00841709106026: The examination table is intended to be used as a chair / table to provide positioning and suppo
• 00841709106019: The examination table is intended to be used as a chair / table to provide positioning and suppo
• 00841709106002: The examination table is intended to be used as a chair / table to provide positioning and suppo
• 00841709105999: The examination table is intended to be used as a chair / table to provide positioning and suppo
• 00841709105982: The examination table is intended to be used as a chair / table to provide positioning and suppo
• 00841709105975: The examination table is intended to be used as a chair / table to provide positioning and suppo
• 00841709116322: The Ritter 230 UltraFree Facial Pad, Latte colored, is designed to increase stability for the he
• 00841709116315: The Ritter 230 UltraFree Facial Pad, Cranberry colored, is designed to increase stability for th
• 00841709116308: The Ritter 230 UltraFree Facial Pad, Restful Path colored, is designed to increase stability for
• 00841709116292: The Ritter 230 UltraFree Facial Pad, Obsidian colored, is designed to increase stability for the
• 00841709116285: The Ritter 230 UltraFree Facial Pad, Dark Linen colored, is designed to increase stability for t
• 00841709116278: The Ritter 230 UltraFree Facial Pad, Stone colored, is designed to increase stability for the he
• 00841709116261: The Ritter 230 UltraFree Facial Pad, Branch colored, is designed to increase stability for the h
• 00841709116254: The Ritter 230 UltraFree Facial Pad, Spice colored, is designed to increase stability for the he
• 00841709116247: The Ritter 230 UltraFree Facial Pad, Wheatgrass colored, is designed to increase stability for t
• 00841709116230: The Ritter 230 UltraFree Facial Pad, Harbor colored, is designed to increase stability for the h
• 00841709116216: The Ritter 230 Facial Pad, Cranberry colored, is designed to increase stability for the head and
• 00841709116193: The Ritter 230 Facial Pad, Obsidian colored, is designed to increase stability for the head and
• 00841709116186: The Ritter 230 Facial Pad, Dark Linen colored, is designed to increase stability for the head an
• 00841709116179: The Ritter 230 Facial Pad, Soothing Blue colored, is designed to increase stability for the head
• 00841709116162: The Ritter 230 Facial Pad, Deep Earth colored, is designed to increase stability for the head an
• 00841709116155: The Ritter 230 Facial Pad, Shaded Garden colored, is designed to increase stability for the head
• 00841709116148: The Ritter 230 Facial Pad, Robust Brown colored, is designed to increase stability for the head
• 00841709116131: The Ritter 230 Facial Pad, Iron Ore colored, is designed to increase stability for the head and