Portex

Portex - 100/179/080

A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated; it does not include an antimicrobial agent(s). The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NTR

Device Name: Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells

Device Class: 1

Physical State: N/A

Definition: MONOCLONAL OR POLYCLONAL ANTIBODY THAT RECOGNIZES THE HUMAN P63 PROTEIN IN THE NUCLEUS OF PROSTATIC BASAL CELLS USING ROUTINE IMMUNOHISTOCHEMICAL TECHNIQUES, INCLUDING HEAT-INDUCED ANTIGEN EPITOPE RETRIEVAL. THIS TEST IS INTENDED FOR LABORATORY USE TO QUALITATIVELY IDENTIFY THE P63 ANTIGEN IN HISTOLOGICAL SECTIONS FROM FORMALIN-FIXED PARAFFIN-EMBEDDED SAMPLES OF NORMAL AND/OR PATHOLOGICAL PROSTATE TISSUE OBTAINED BY NEEDLE BIOPSY OR SURGICAL PROCEDURES. THE PRESENCE OR ABSENCE OF P63 STAINING AIDS THE PATHOLOGIST IN THE DIFFERENTIAL DIAGNOSIS OF PROSTATE CANCER IN CONJUNCTION WITH MORPHOLOGICAL FINDINGS SEEN WITH HEMATOXYLIN AND EOSIN STAINING COMPLEMENTED BY PROPER CONTROLS.

Submission Type ID: 4

Review Panel: PA

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: 864.1860

Third Party Flag: N

Medical Specialty: HE

Device Id: 55019315022140

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 35019315022146

Package Quantity: 12

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

Device Id: 35019315022146

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 15019315022142

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box

Device Id: 15019315022142

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