RenalCryo™ R3.8L

GUDID 00810563020267

Endocare™ 3.8mm Long Shaft RenalCryo™ 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: 00810563020267
• NIH Device Record Key: c6eb1751-4361-422b-b713-b08e26c9ed6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RenalCryo™
• Version Model Number: R3.8L
• Catalog Number: R3.8L
• 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: 3.8 Millimeter
• Outer Diameter: 3.8 Millimeter
• Outer Diameter: 3.8 Millimeter
• Outer Diameter: 3.8 Millimeter
• Outer Diameter: 3.8 Millimeter
• Outer Diameter: 3.8 Millimeter
• Outer Diameter: 3.8 Millimeter
• Outer Diameter: 3.8 Millimeter
• Outer Diameter: 3.8 Millimeter
• Outer Diameter: 3.8 Millimeter
• Outer Diameter: 3.8 Millimeter
• Outer Diameter: 3.8 Millimeter
• Outer Diameter: 3.8 Millimeter
• Outer Diameter: 3.8 Millimeter
• Outer Diameter: 3.8 Millimeter
• Outer Diameter: 3.8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810563020267 [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: 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 [RenalCryo™]

• 00810563020267: Endocare™ 3.8mm Long Shaft RenalCryo™ Cryoprobe
• 00810563020250: Endocare™ 3.8mm RenalCryo™ Cryoprobe
• 00810563020076: Endocare™ 2.4 mm RenalCryo™ Long Shaft Cryoprobe
• 00810563020069: Endocare™ 2.4 mm RenalCryo™ Cryoprobe
• 00810563020052: Endocare™ 1.7 mm RenalCryo™ Long Shaft Cryoprobe
• 00810563020045: Endocare™ 1.7 mm RenalCryo™ Cryoprobe