CryoMini 4009

GUDID 04053815003083

Zimmer MedizinSysteme GmbH

Cold-air therapy unit Localized cutaneous/musculoskeletal cryotherapy unit Localized cutaneous/musculoskeletal cryotherapy unit Localized cutaneous/musculoskeletal cryotherapy unit Localized cutaneous/musculoskeletal cryotherapy unit Localized cutaneous/musculoskeletal cryotherapy unit Localized cutaneous/musculoskeletal cryotherapy unit Localized cutaneous/musculoskeletal cryotherapy unit Localized cutaneous/musculoskeletal cryotherapy unit Localized cutaneous/musculoskeletal cryotherapy unit Localized cutaneous/musculoskeletal cryotherapy unit Localized cutaneous/musculoskeletal cryotherapy unit

• Primary Device ID: 04053815003083
• NIH Device Record Key: a1aca697-d465-44f1-a31f-3488d5d8e3b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CryoMini
• Version Model Number: 4009
• Catalog Number: 4009
• Company DUNS: 316111251
• Company Name: Zimmer MedizinSysteme GmbH
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053815003083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080735

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2016-09-24

On-Brand Devices [CryoMini]

• 04053815003090: 4011
• 04053815003083: 4009