HANDPIECE 1897201 STRAIGHTSHOT III

HANDPIECE 1897201 STRAIGHTSHOT III
XPS® Straightshot® - 1897201

An assembly of devices designed to resect bones, tough tissues (e.g., cartilage, ligaments), and soft tissues during a surgical procedure; it is not dedicated to a specific clinical application. It includes a mains electricity (AC-powered) control unit which supplies low-voltage electricity, motors/handpieces/power tool attachments, and a variety of tools (e.g., drill bits, saw blades, burs, milling cutters, shavers, screwdriver bits, guide wires).

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Ethylene Oxide
• Moist Heat or Steam Sterilization

Code: MUU

Device Name: System, Suction, Lipoplasty

Device Class: 2

Physical State: N/A

Definition: See Federal Register Notice at 86 FR 50887 “Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Products at the Point of Care to Produce a Therapeutic Article” (FRN) (FDA-2021-N-0881).

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: 878.5040

Third Party Flag: N

Medical Specialty: SU

Device Id: 00681490693950

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