PerCryo™ PCS-17R

GUDID 00810563020014

Endocare™ 1.7 mm PerCryo™ Round Ice Cryoprobe

ENDOCARE, INC.

Cryosurgical set

• Primary Device ID: 00810563020014
• NIH Device Record Key: c63aa6f0-27c4-4a91-bdad-3b0a6c6f9c7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PerCryo™
• Version Model Number: PCS-17R
• Catalog Number: PCS-17R
• 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: 1.7 Millimeter
• Outer Diameter: 1.7 Millimeter
• Outer Diameter: 1.7 Millimeter
• Outer Diameter: 1.7 Millimeter
• Outer Diameter: 1.7 Millimeter
• Outer Diameter: 1.7 Millimeter
• Outer Diameter: 1.7 Millimeter
• Outer Diameter: 1.7 Millimeter
• Outer Diameter: 1.7 Millimeter
• Outer Diameter: 1.7 Millimeter
• Outer Diameter: 1.7 Millimeter
• Outer Diameter: 1.7 Millimeter
• Outer Diameter: 1.7 Millimeter
• Outer Diameter: 1.7 Millimeter
• Outer Diameter: 1.7 Millimeter
• Outer Diameter: 1.7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810563020014 [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 [PerCryo™]

• 00810563020496: Endocare™ 1.7mm PerCryo™ Short Cryoprobe
• 00810563020038: Endocare™ 2.4 mm PerCryo™ Long Shaft Cryoprobe
• 00810563020021: Endocare™ 2.4 mm PerCryo™ Cryoprobe
• 00810563020014: Endocare™ 1.7 mm PerCryo™ Round Ice Cryoprobe
• 00810563020007: Endocare™ 1.7mm PerCryo™ Cryoprobe