Sterilizer,steam

Sterilizer,steam
Model 4472 - 4472-2V

A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, or steam. It typically includes a treatment chamber with shelves for device placement, and controls; it may be intended to sterilize wrapped and/or unwrapped devices. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PDG

Device Name: Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.

Device Class: 2

Physical State: Applicator/Dissector, RF Generator and Battery are integrated in a single handpiece.

Definition: Intended for any procedure where vessel ligation (cutting and sealing), soft tissue grasping and dissection are performed.

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Application of RF energy to heat and seal vessel/tissue followed by dissection of target vessel/tissue.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures.

Regulation Number: 878.4400

Third Party Flag: Y

Medical Specialty: SU

Device Id: 07290110640668

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