N/A CRYO-63

GUDID 00810563020342

Endocare™ Urethral Warming System

ENDOCARE, INC.

General cryosurgical system, cryogen gas, mechanical

• Primary Device ID: 00810563020342
• NIH Device Record Key: 4aea9b47-22de-4117-94e1-74c8c46c3614
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: CRYO-63
• Catalog Number: CRYO-63
• 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: true
• Serial Number: false
• 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: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx
• Phone: 5123282892
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810563020342 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963970

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: 2016-07-31

On-Brand Devices [N/A]

• 00810563020427: Endocare™ Prostate Procedure Probe Pack 4 x CVA2400 6 x CRYO-55-F 1 x CRYO-77
• 00810563020397: Endocare™ Prostate Procedure Probe Pack 6 x CVA2400 6 x CRYO-55-F 1 x CRYO-77
• 00810563020380: Endocare™ Urethral Warming Catheter Kit
• 00810563020342: Endocare™ Urethral Warming System
• 00810563020106: Endocare™ 8mm Cryoprobe