Cryocare CS™ Surgical System CRYO-CS-3 Version 5

GUDID 00816389028876

Cryosurgical system console with ultrasound unit

VARIAN MEDICAL SYSTEMS, INC.

General cryosurgical system, cryogen gas, electronic

• Primary Device ID: 00816389028876
• NIH Device Record Key: a6f3f0b8-939e-4b86-b967-cdac196ca848
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cryocare CS™ Surgical System
• Version Model Number: DP35-0684-108
• Catalog Number: CRYO-CS-3 Version 5
• Company DUNS: 009120817
• Company Name: VARIAN MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816389028876 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153489

FDA Product Code

• GEH: UNIT, CRYOSURGICAL, ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-28
• Device Publish Date: 2022-02-18

On-Brand Devices [Cryocare CS™ Surgical System]

• 00816389028883: Cryosurgical system console
• 00816389028876: Cryosurgical system console with ultrasound unit