Acessa ProVu Dual Foot Pedal

GUDID 00854763006256

Pneumatic foot pedals with tubing used to turn RF energy on and off.

ACESSA HEALTH INC.

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• Primary Device ID: 00854763006256
• NIH Device Record Key: 2f704d83-099c-48f8-9399-1b80649fb67c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acessa ProVu Dual Foot Pedal
• Version Model Number: MS-06-0171
• Company DUNS: 080935394
• Company Name: ACESSA HEALTH 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: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854763006256 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181124

FDA Product Code

• HFG: Coagulator, Laparoscopic, Unipolar (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: 2020-12-15
• Device Publish Date: 2020-12-07

Devices Manufactured by ACESSA HEALTH INC.

• 00854763006256 - Acessa ProVu Dual Foot Pedal: 2020-12-15Pneumatic foot pedals with tubing used to turn RF energy on and off.
• 00854763006256 - Acessa ProVu Dual Foot Pedal: 2020-12-15 Pneumatic foot pedals with tubing used to turn RF energy on and off.
• 00854763006102 - Acessa Pads: 2018-11-12 Acessa Pads, disposable dispersive pad, connects to the Acessa ProVu Console Legacy #854763006010
• 00854763006119 - Acessa Pad Cable: 2018-11-12 Acessa Pad Cable, Reusable, connects to the Acessa ProVu Console Legacy DI #854763006072
• 00854763006126 - Acessa Table Top Field Generator: 2018-11-12 Acessa Table Top Field Generator (TTFG), connects to the Acessa ProVu Console. Includes TTFG Pad Set
• 00854763006140 - Acessa ProVu Handpiece: 2018-11-12 Disposable Handpiece connects to Acessa ProVu Console
• 00854763006157 - Acessa ProVu Handpiece Cable: 2018-11-12 Acessa ProVu Handpiece Cable, Reusable, Connects to the Acessa ProVu Console
• 00854763006188 - Acessa ProVu Transducer with sensor: 2018-11-12 Acessa ProVu Transducer with sensor, Reusable, connects to the Acessa ProVu Console
• 00854763006195 - Acessa ProVu Planar Field Generator (PFG): 2018-11-12 Acessa ProVu Planar Field Generator (PFG), connects to the ProVu Console