- Physicians Office Resource

INTERFACE FOR ESU(FORCE SERIES) - MAJ-1832

Device Description

A device intended to allow electrical connection of incompatible plugs/sockets on related medical devices (e.g., generator and controller) and/or cables. This device will typically be used when the system components are from different manufacturers or using different technologies, and the original connectors are not compatible; it has no additional non-electrical conduction or processing functionality. This is a reusable device.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: GCJ

Device Name: Laparoscope, General & Plastic Surgery

Device Class: 2

Physical State: N/A

Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Submission Type ID: 1

Review Panel: SU

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: 876.1500

Third Party Flag: N

Medical Specialty: GU

Code: ODA

Device Name: Endoscopic Central Control Unit

Device Class: 2

Physical State: may include: monitor, remote (or other wireless device), microphone, card adaptor, cables, other hardware and software

Definition: To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Connect operating systems into central control unit

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: endoscopic and other ancillary surgical equipment

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Identifiers

Device Id: 04953170291531

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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