Varian CRYOCARE TOUCH™ System

GUDID 00810563020649

ENDOCARE, INC.

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• Primary Device ID: 00810563020649
• NIH Device Record Key: 7f5af895-e332-4cd8-9e4e-d764fa9240e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Varian CRYOCARE TOUCH™ System
• Version Model Number: CRYO-38T
• Company DUNS: 928955509
• Company Name: ENDOCARE, 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: 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	00810563020649 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201588

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: 2020-08-24
• Device Publish Date: 2020-08-14

Devices Manufactured by ENDOCARE, INC.

• 00810563022032 - ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, Ellipsoidal: 2023-04-28
• 00810563022049 - ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, Spherical: 2023-04-28
• 00810563022056 - ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, Ellipsoidal: 2023-04-28
• 00810563022063 - ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, Spherical: 2023-04-28
• 00810563020977 - Urethral Warming Catheter Kit: 2022-02-11 Urethral Warming catheter for use in tissue warmning during cryosurgical procedures with the Cryocare systems
• 00810563020649 - Varian CRYOCARE TOUCH™ System: 2020-08-24
• 00810563020649 - Varian CRYOCARE TOUCH™ System: 2020-08-24
• 00810563020595 - SynchroWave Antenna Kit: 2020-01-09 15cm Short Tip Antenna and Cooling Circuit
• 00810563020540 - SynchroWave Antenna Kit: 2020-01-09 20cm Long Tip Antenna and Cooling Circuit