ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, Spherical

GUDID 00810563022063

ENDOCARE, INC.

Cryosurgical set

• Primary Device ID: 00810563022063
• NIH Device Record Key: a5e89cee-8a04-4f23-9df4-f1abc23b3ad8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, Spherical
• Version Model Number: PC-2.1SL
• 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: false
• 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	00810563022063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230271

FDA Product Code

• GEH: UNIT, CRYOSURGICAL, ACCESSORIES

Sterilization

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

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[00810563022063]

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[00810563022063]

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[00810563022063]

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[00810563022063]

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[00810563022063]

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[00810563022063]

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[00810563022063]

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[00810563022063]

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[00810563022063]

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[00810563022063]

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[00810563022063]

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[00810563022063]

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[00810563022063]

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[00810563022063]

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[00810563022063]

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[00810563022063]

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[00810563022063]

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[00810563022063]

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[00810563022063]

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Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-28
• Device Publish Date: 2023-04-20

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