Urethral Warming Catheter Kit CRYO-77

GUDID 00810563020977

Urethral Warming catheter for use in tissue warmning during cryosurgical procedures with the Cryocare systems

ENDOCARE, INC.

Cryosurgical set

• Primary Device ID: 00810563020977
• NIH Device Record Key: e13d44ed-ba25-4597-b7fb-c7e97a5d4b37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Urethral Warming Catheter Kit
• Version Model Number: DP40-0141-106
• Catalog Number: CRYO-77
• Company DUNS: 928955509
• Company Name: ENDOCARE, 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	00810563020977 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211149

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: 2022-02-11
• Device Publish Date: 2022-02-03

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