3.8 mm RenalCryo™ Cryoprobe R3.8

GUDID 00810563020861

Right angle 3.8mm cryoprobe, oblong ice, for use with Cryocare systems

VARIAN MEDICAL SYSTEMS, INC.

Ophthalmic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 00810563020861
• NIH Device Record Key: 8fa63a55-87fb-4bf5-8669-646892188048
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.8 mm RenalCryo™ Cryoprobe
• Version Model Number: DP35-0793-201
• Catalog Number: R3.8
• Company DUNS: 009120817
• Company Name: VARIAN MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810563020861 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-28
• Device Publish Date: 2022-02-18

On-Brand Devices [3.8 mm RenalCryo™ Cryoprobe]

• 00810563020878: Right angle 3.8mm cryoprobe, oblong ice, for use with Cryocare systems (Lead-Free)
• 00810563020861: Right angle 3.8mm cryoprobe, oblong ice, for use with Cryocare systems