Console

Console
Crossfire - 0475000000

A mains electricity (AC-powered) device designed to provide energy for a system designed to perform arthroscopic shaving (i.e., abrasion, resection, debridement of bone and soft tissue with a blade) and electrosurgical diathermy (i.e., the ablation and coagulation of soft tissue, as well as haemostasis of blood vessels, with an electrosurgical probe) during arthroscopic procedures on a joint. The unit typically consists of an operational display, operator controls, and software to help provide optimal parameters for the connected shaver handpiece(s) and electrosurgical probe(s). It may include an irrigation system.

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Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: HRX

Device Name: Arthroscope

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: OR

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: 888.1100

Third Party Flag: Y

Medical Specialty: OR

Code: GEI

Device Name: Electrosurgical, Cutting & Coagulation & Accessories

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: 878.4400

Third Party Flag: Y

Medical Specialty: SU

Device Id: 07613327058086

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