RenalCryo™ R3.8L

GUDID 00810563020267

Endocare™ 3.8mm Long Shaft RenalCryo™ Cryoprobe

ENDOCARE, INC.

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