Prostate Procedure Probe Pack CRYO-204-V

GUDID 00810563020915

Prostate Procedure Kit containing CVA2400 (4ea), CRYO-55-F (6 ea), CRYO-77 ( 1 ea)

VARIAN MEDICAL SYSTEMS, INC.

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

• Primary Device ID: 00810563020915
• NIH Device Record Key: 17fd8bb3-ee85-425f-b884-a86ee211a10b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prostate Procedure Probe Pack
• Version Model Number: DP35-0965-101
• Catalog Number: CRYO-204-V
• 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	00810563020915 [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 [Prostate Procedure Probe Pack]

• 00810563020939: Prostate Procedure Kit containing CVA2400 (6ea), CRYO-55-F (6 ea), CRYO-77 ( 1 ea)
• 00810563020915: Prostate Procedure Kit containing CVA2400 (4ea), CRYO-55-F (6 ea), CRYO-77 ( 1 ea)