TargetCool

GUDID 08800073100049

RecensMedical, Inc.

General cryosurgical system, cryogen gas, mechanical

• Primary Device ID: 08800073100049
• NIH Device Record Key: e713d4b2-f8ed-4600-894a-22a8b96423a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TargetCool
• Version Model Number: RM-DC04W
• Company DUNS: 694808508
• Company Name: RecensMedical, 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800073100049 [Primary]

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-07
• Device Publish Date: 2022-11-29

Devices Manufactured by RecensMedical, Inc.

• 08800073100049 - TargetCool: 2022-12-07
• 08800073100049 - TargetCool: 2022-12-07
• 08800073100018 - CryoVIVE: 2021-07-05