SMK-C1010-18

GUDID 05415067028723

Radiofrequency Cannula - Curved

ST. JUDE MEDICAL, INC.

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cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use

• Primary Device ID: 05415067028723
• NIH Device Record Key: 9f3deb9f-2edb-43a9-ad74-80fe97f74efa
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SMK-C1010-18
• Catalog Number: SMK-C1010-18
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
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• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter
• Needle Gauge: 18 Gauge
• Length: 10 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067028723 [Primary]
GS1	15415067028720 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• GXI: PROBE, RADIOFREQUENCY LESION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-25
• Device Publish Date: 2017-04-10

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• 05415067050281 - EnSite™: 2024-04-04 X EP System PFA Catheter Visualization Temporary Software License
• 05415067050298 - EnSite™: 2024-04-04 X EP System PFA Catheter Visualization Software License
• 05415067049650 - NA: 2024-04-03 Grounding Pad
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• 05415067044655 - Rigid Saddle Ring: 2024-02-12 Rigid Saddle Ring