M11 Ultraclave M11-021

GUDID 00841709100116

The M11 Ultraclave 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

MIDMARK CORPORATION

Steam sterilizer

• Primary Device ID: 00841709100116
• NIH Device Record Key: 08048f2d-aefe-4a05-9ca7-f023d17a71d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M11 Ultraclave
• Version Model Number: M11-021
• Catalog Number: M11-021
• 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: false
• 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)634-6286
• Email: telemarketing@midmark.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841709100116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990189

FDA Product Code

• FLE: Sterilizer, Steam

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [M11 Ultraclave]

• 00841709100130: The M11 Ultraclave can be used in medical and dental offices, hospitals, clinics, nursing homes,
• 00841709100116: The M11 Ultraclave can be used in medical and dental offices, hospitals, clinics, nursing homes,
• 00841709100109: "The M11 Ultraclave can be used in medical and dental offices, hospitals, clinics,nursing homes,