N/A CRYO-48

GUDID 00810563020106

Endocare™ 8mm Cryoprobe

ENDOCARE, INC.

Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set

• Primary Device ID: 00810563020106
• NIH Device Record Key: ae0454ff-8abc-4c69-b4c2-795bfb40ddeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: CRYO-48
• Catalog Number: CRYO-48
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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

Device Dimensions

• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810563020106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011074

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

Sterilization

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

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