- Physicians Office Resource

CoPilot System
Auto Suture - 098002

Device Description

A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Environmental Conditions

Handling Environment Temperature - Degrees Fahrenheit

130.00
N/A

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: IZD

Device Name: Probe, Uptake, Nuclear

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: RA

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: 892.1320

Third Party Flag: N

Medical Specialty: RA

Device Identifiers

Device Id: 20884521184463

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521184466

Package Quantity: 12

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

Device Id: 10884521184466

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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