- Physicians Office Resource

The Acessa ProVu Table Top Field Generator
Acessa ProVu System - 5200

Device Description

An electrically powered device intended to generate an electromagnetic (EM) field for tracking of surgical instruments with respect to real-time ultrasound images during surgery. It is designed to be connected to a control unit which is in turn connected to an endoscopic handpiece and ultrasound transducer which both feature magnetic guidance sensors. It is used for multiple surgical procedures (e.g., ethmoidectomy, tumour resection, fibroid ablation, biopsy, drilling, vascular access) in various fields [e.g., ENT, craniomaxillofacial (CMF), laparoscopic, or orthopaedic surgery]. This is a reusable device.

Environmental Conditions

Handling Environment Temperature - Degrees Celsius

30.00
10.00

Storage Environment Temperature - Degrees Celsius

65.00
-34.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: HFG

Device Name: Coagulator, Laparoscopic, Unipolar (And Accessories)

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OB

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 884.4160

Third Party Flag: Y

Medical Specialty: OB

Device Identifiers

Device Id: 15420045515284

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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