Certus® 140 DR-000551

GUDID 00853719006166

Certus 140 2.45GHz Ablation System, 120 VAC

NEUWAVE MEDICAL, INC.

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• Primary Device ID: 00853719006166
• NIH Device Record Key: 1021043b-1ba5-4707-ab29-d7bc23310ba2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Certus® 140
• Version Model Number: 2.45 GHz Ablation System
• Catalog Number: DR-000551
• Company DUNS: 809758878
• Company Name: NEUWAVE MEDICAL, 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: 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: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com
• Phone: +1(877)323-9283
• Email: info@neuwave.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853719006166 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-18

On-Brand Devices [Certus® 140]

• 00853719006234: Surgical Dual Probe Kit
• 00853719006227: Footswitch, 3M, Gen2
• 00853719006210: Footswitch, 4M, Gen1
• 00853719006180: Certus 140 2.45GHz Ablation System, with Ablation Confirmation, 120 VAC
• 00853719006166: Certus 140 2.45GHz Ablation System, 120 VAC
• 00853719006159: Dual Probe Clip, 17 Gauge
• 00853719006142: Dual Probe Clip, 17 Gauge, 5 Pack
• 00853719006135: SR25cm-13ga CertusSR Ablation Probe, 25 cm, 13 ga
• 00853719006128: CertuSurgGT CertuSurgGT Surgical Tool, 6 cm, 17 ga
• 00853719006104: LN20cm-17ga CertusLN Ablation Probe, 20 cm, 17 ga
• 00853719006081: LN15cm-17ga CertusLN Ablation Probe, 15 cm, 17 ga
• 00853719006074: LK20cm-15ga CertusLK Ablation Probe, 20 cm, 15 ga
• 00853719006067: LK15cm-15ga CertusLK Ablation Probe, 15 cm, 15 ga
• 00853719006050: LK20cm-17ga CertusLK Ablation Probe, 20 cm, 17 ga
• 00853719006043: LK15cm-17ga CertusLK Ablation Probe, 15 cm, 17 ga
• 00853719006036: PR20cm-15ga CertusPR Ablation Probe, 20 cm, 15 ga
• 00853719006029: PR15cm-15ga CertusPR Ablation Probe, 15 cm, 15 ga
• 00853719006012: PR20cm-17ga CertusPR Ablation Probe, 20 cm, 17 ga
• 00853719006005: PR15cm-17ga CertusPR Ablation Probe, 15 cm, 17 ga