M9 Ultraclave M9-020

GUDID 00841709100048

"The M9 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: 00841709100048
• NIH Device Record Key: 1b297cb1-18ed-4755-afa5-3976d6f23573
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M9 Ultraclave
• Version Model Number: M9-020
• Catalog Number: M9-020
• 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)634-6279
• 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	00841709100048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023348

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 [M9 Ultraclave]

• 00841709100086: "The M9 Ultraclave can be used in medical and dental offices, hospitals, clinics,nursing homes,
• 00841709100055: "The M9 Ultraclave can be used in medical and dental offices, hospitals, clinics,nursing homes,
• 00841709100048: "The M9 Ultraclave can be used in medical and dental offices, hospitals, clinics,nursing homes,