NEUWAVE ARM2

GUDID 00853719006982

NEUWAVE Arm 2 Dovetail Rail

NEUWAVE MEDICAL, INC.

Microwave ablation system generator

• Primary Device ID: 00853719006982
• NIH Device Record Key: 85cd3edc-6815-4f45-8022-91304297e7f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEUWAVE
• Version Model Number: ARM2
• Catalog Number: ARM2
• Company DUNS: 809758878
• Company Name: NEUWAVE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853719006982 [Primary]

FDA Product Code

• BWN: TABLE AND ATTACHMENTS, OPERATING-ROOM

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: 2018-09-26
• Device Publish Date: 2018-08-26

On-Brand Devices [NEUWAVE]

• 00853719006302: NEUWAVE Flex System, US
• 00853719006982: NEUWAVE Arm 2 Dovetail Rail
• 00853719006975: NEUWAVE Arm 1 OR Table Rail
• 00853719006555: NEUWAVE Ablation System, US
• 00853719006999: NEUWAVE Ablation System with Ablation Confirmation, US
• 00853719006531: Surgical Probe Kit
• 00853719006524: Surgical PDM Mount Kit
• 00853719006517: Footswitch Locking USB
• 00853719006500: Footswitch Standard USB
• 00853719006548: Dual Resection Probe Clip
• 00853719006487: CT Bed Rail Mount, Siemens Alt
• 00853719006470: CT Bed Rail Mount, Toshiba
• 00853719006463: CT Bed Rail Mount, Siemens
• 00853719006456: CT Bed Rail Mount, GE/Philips
• 00853719006449: NEUWAVE Surgical Tool
• 00853719006432: NEUWAVE SR Probe 25CM 13ga
• 00853719006425: NEUWAVE PR XT Probe 20CM 15ga
• 00853719006418: NEUWAVE PR Probe 20CM 17ga
• 00853719006401: NEUWAVE PR XT Probe 15CM 15ga
• 00853719006395: NEUWAVE PR Probe 15CM 17ga
• 00853719006388: NEUWAVE LK XT Probe 20CM 15ga
• 00853719006371: NEUWAVE LK Probe 20CM 17ga
• 00853719006364: NEUWAVE LK XT Probe 15CM 15ga
• 00853719006357: NEUWAVE LK Probe 15CM 17ga
• 00853719006340: NEUWAVE LN Probe 20CM 17ga
• 00853719006333: NEUWAVE LN Probe 15CM 17ga
• 00853719006326: NEUWAVE Flex Probe 6
• 00853719006319: NEUWAVE Flex Probe 4
• 10818913020506: NEUWAVE PRS Probe 15CM 15ga
• 00818913020189: NEUWAVE Flex MAS, 220-230VAC
• 00818913020172: NW CERTUS Flex System, China
• 00818913020158: NW Flex System, Singapore
• 00818913020073: NW Flex System, Hong Kong
• 00853719006753: NW Ablation System, US
• 00818913020523: Surgical Clip, Dual, 15ga or 17ga Probe, 5 Pack
• 00818913020257: Upgrade to Certus 140-2.45GHz Ablation Confirmation
• 00818913020196: NW Flex System, US
• 00818913020677: CT Bed Rail Mount, Flat
• 20818913020695: NW SURGICAL PR PROBE 35CM 11GA