Cryo 6 7343

GUDID 04053815044642

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: 04053815044642
• NIH Device Record Key: c156fe6e-c731-41b6-9818-3de528e90907
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cryo 6
• Version Model Number: 7343
• Catalog Number: 7343
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053815044642 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090618

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 [Cryo 6]

• 04053815044642: 7343
• 04053815044635: 7342
• 04053815003618: 7310