STYLET 628285 US DS KNOB ST
NA - 628285
Device Description
A sterile wire, intended to be percutaneously inserted into the coronary venous vasculature to aid in the transvenous placement and/or removal of implantable pacemaker/defibrillator leads; it may in addition be intended to extract an indwelling catheter or other foreign object. It is manipulated proximally with a handle, and its working end is typically made of extremely thin stainless steel wire (e.g., 0.4 mm to 0.81 mm in diameter), and may be available in various wire lengths and degrees of rigidity. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Outer Diameter: 0.356 Millimeter
- Length: 85.0 Centimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DRB
Device Name: Stylet, Catheter
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
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: 870.1380
Third Party Flag: Y
Medical Specialty: CV
Device IdentifiersDevice Id: 20613994618669
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00613994618665
Package Quantity: 5
Package Discontinue Date: 5/10/2022 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: PK
Device Id: 00613994618665
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