IntelliBlate Ximitry Probe Assembly, 13G x 15cm

GUDID 10810563022299

IntelliBlate Ximitry probe assembly includes cassette with saline tubing, laser alignment disc, and microwave ablation probe 13G/15cm Probe QTY 1

ENDOCARE, INC.

Microwave ablation system probe, electrically-powered

• Primary Device ID: 10810563022299
• NIH Device Record Key: 32d76bef-6e1c-4c4c-8ddb-638bf1b55e4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IntelliBlate Ximitry Probe Assembly, 13G x 15cm
• Version Model Number: IB-XPA-1315
• 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	00810563022292 [Primary]
GS1	10810563022299 [Package]; Contains: 00810563022292; Package: [3 Units]; In Commercial Distribution
GS1	20810563022296 [Package]; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240480

FDA Product Code

• NEY: SYSTEM, ABLATION, MICROWAVE AND 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: 2024-08-19
• Device Publish Date: 2024-08-09

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: 2024-08-19IntelliBlate Ximitry probe assembly includes cassette with saline tubing, laser alignment disc, and microwave ablation probe 13G/15cm Probe QTY 1
• 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