Portex - 4143
Device Description
A cap/cover intended to be extended over a used needle (attached to a syringe/autoinjector or not) to prevent accidental needle sticks, typically during removal of the needle. It is typically a plastic housing with appropriate shielding to prevent injury upon application, and is typically disposed of with the needle; it is not the needle cap provided with the needle. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: FMI
Device Name: Needle, Hypodermic, Single Lumen
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: HO
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: 880.5570
Third Party Flag: Y
Medical Specialty: HO
Device IdentifiersDevice Id: 30351688051053
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10351688051059
Package Quantity: 3
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
Device Id: 10351688051059
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 20351688051056
Package Quantity: 1000
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BAG
Device Id: 20351688051056
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
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