Portex - 100/199/095
Device Description
A device intended to replace the head of some types of surgical mallets and hammers. It is typically a solid cylinder of various diameters with flat ends; it is made of durable, non-splintering, synthetic polymer materials and is fixed (typically screwed using it's central screw thread) to the the distal end of the mallet. This is a reusable 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: 35019315022375
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15019315022371
Package Quantity: 20
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX
Device Id: 15019315022371
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: 55019315022379
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 35019315022375
Package Quantity: 6
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE