SynchroWave Antenna BT Adapter SWBT-AB

GUDID 00810563020601

SynchroWave Antenna BT Adapter Package

ENDOCARE, INC.

Microwave ablation system generator

• Primary Device ID: 00810563020601
• NIH Device Record Key: b618c355-2c84-4f7d-8cef-a77af52832a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SynchroWave Antenna BT Adapter
• Version Model Number: SWBT-AB
• Catalog Number: SWBT-AB
• Company DUNS: 928955509
• Company Name: ENDOCARE, 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com
• Phone: 8774672009
• Email: customerservice@endocare.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810563020601 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141785

FDA Product Code

• NEY: System, Ablation, Microwave And 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: 2019-04-12
• Device Publish Date: 2019-04-04

Devices Manufactured by ENDOCARE, INC.

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• 00810563022285 - IntelliBlate Microwave Ablation System Mobile Cart: 2024-08-19 Mobile cart only for IntelliBlate microwave ablation system
• 10810563022299 - IntelliBlate Ximitry Probe Assembly, 13G x 15cm: 2024-08-19 IntelliBlate Ximitry probe assembly includes cassette with saline tubing, laser alignment disc, and microwave ablation probe 13G
• 10810563022305 - IntelliBlate Ximitry Probe Assembly, 13G x 20cm: 2024-08-19 IntelliBlate Ximitry probe assembly includes cassette with saline tubing, Ximitry laser alignment disc, and microwave ablation p
• 10810563022312 - IntelliBlate Ximitry Probe Assembly, 13G x 27cm: 2024-08-19 IntelliBlate Ximitry probe assembly includes cassette with saline tubing, laser alignment disc, and microwave ablation probe 13G
• 10810563022329 - Temperature Sensor Probe, 18G x 20cm: 2024-08-19 Ablation accessory: disposable temperature probe, 18G/20cm Probe QTY 1
• 00810563022032 - ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, Ellipsoidal: 2023-04-28
• 00810563022049 - ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, Spherical: 2023-04-28