Portex - 100/199/090
Device Description
A viscous, proteinaceous substance that is topically applied to a wound bed to provide a temporary (degradable) matrix of structural proteins (animal-derived) for the attachment of native cells, to promote wound healing. It is typically contained within a syringe and applied with an applicator. It is intended as a primary dressing typically for hard-to-heal ulcers (e.g., venous leg ulcers), and is covered with a secondary dressing. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: BTR
Device Name: Tube, Tracheal (W/Wo Connector)
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: AN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: Y
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 868.5730
Third Party Flag: N
Medical Specialty: AN
Device IdentifiersDevice Id: 35019315022368
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15019315022364
Package Quantity: 20
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX
Device Id: 15019315022364
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
Device Id: 55019315022362
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 35019315022368
Package Quantity: 6
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE