Portex

Portex - CE423

A device or collection of devices that includes a flexible polymer tube intended to be used primarily to transfer gametes (eggs or sperm) and/or embryos into the female reproductive tract for the purpose of assisted reproduction [e.g., intrauterine insemination (IUI) or gamete intrafallopian transfer (GIFT)]. In addition to the ‘live transfer’ catheter it may also include a trial transfer catheter intended to assess/ensure that embryo placement will be successful; it typically also includes devices intended to assist catheter introduction (e.g., outer guide sheath, stylet). 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: MQF

Device Name: Catheter, Assisted Reproduction

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OB

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: 884.6110

Third Party Flag: Y

Medical Specialty: OB

Device Id: 35019315012598

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 15019315012594

Package Quantity: 10

Package Discontinue Date: 9/27/2019 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Carton

Device Id: 15019315012594

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