Wallach UltraFreeze

GUDID 00888937009750

Closed-End Tip Cryosurgical Equipment

Coopersurgical, Inc.

General cryosurgical system, cryogen gas, mechanical

• Primary Device ID: 00888937009750
• NIH Device Record Key: b14143aa-e09f-437d-826b-6bade982d697
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wallach UltraFreeze
• Version Model Number: 900090
• Company DUNS: 801895244
• Company Name: Coopersurgical, Inc.
• 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: false
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937009750 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935010

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

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: 2016-07-29

On-Brand Devices [Wallach UltraFreeze]

• 00888937009781: Mini-Flat Closed-End Tip Cryosurgical Equipment
• 00888937009767: Mini-Flat Closed-End Tip Cryosurgical Equipment
• 00888937009750: Closed-End Tip Cryosurgical Equipment