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 Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set 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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• 00810563022063 - ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, Spherical: 2023-04-28
• 00810563020977 - Urethral Warming Catheter Kit: 2022-02-11Urethral Warming catheter for use in tissue warmning during cryosurgical procedures with the Cryocare systems
• 00810563020977 - Urethral Warming Catheter Kit: 2022-02-11 Urethral Warming catheter for use in tissue warmning during cryosurgical procedures with the Cryocare systems
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