DF4 Helix Locking Tool

GUDID 00810024671724

The DF4 Helix Locking Tool is a sterile, single-use device compatible with pacing and/or defibrillator leads with an extendable-retractable fixation helix and an DF4 connector with terminal pin. The DF4 Helix Locking Tool is press-fit to the lead terminal pin to fix in place or, upon rotation, transfer torque to the helix electrode. The lead helix may be extended or retracted based on the direction of torque applied. The tool may also guide stylet insertion into the lead.

CENTERPOINT SYSTEMS LLC

Torque manipulation device

• Primary Device ID: 00810024671724
• NIH Device Record Key: abb3c1a6-847c-45fa-875f-8e9b59bc112b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DF4 Helix Locking Tool
• Version Model Number: A002HELX
• Company DUNS: 117126091
• Company Name: CENTERPOINT SYSTEMS LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 54 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810024671724 [Primary]

FDA Product Code

• DWS: Instruments, Surgical, Cardiovascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-11
• Device Publish Date: 2025-12-03

Devices Manufactured by CENTERPOINT SYSTEMS LLC

• 00810024671724 - DF4 Helix Locking Tool: 2025-12-11The DF4 Helix Locking Tool is a sterile, single-use device compatible with pacing and/or defibrillator leads with an extendable-retractable fixation helix and an DF4 connector with terminal pin. The DF4 Helix Locking Tool is press-fit to the lead terminal pin to fix in place or, upon rotation, transfer torque to the helix electrode. The lead helix may be extended or retracted based on the direction of torque applied. The tool may also guide stylet insertion into the lead.
• 00810024671724 - DF4 Helix Locking Tool: 2025-12-11 The DF4 Helix Locking Tool is a sterile, single-use device compatible with pacing and/or defibrillator leads with an extendable-
• 00810024670987 - CPS Locator 3D Delivery Catheter: 2025-07-15 The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillator leads.
• 00810024670994 - CPS Locator 3D Delivery Catheter: 2025-07-15 The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillation leads.
• 00810024671007 - CPS Locator 3D Delivery Catheter: 2025-07-15 The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillation leads.
• 00810024671069 - CPS Locator 3D Delivery Catheter: 2025-07-15 The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillation leads.
• 00810024671076 - CPS Locator 3D Delivery Catheter: 2025-07-15 The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillation leads.
• 00810024671083 - CPS Locator 3D Delivery Catheter: 2025-07-15 The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillation leads.
• 00810024671199 - AuST Steerable Sheath: 2025-03-19 The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, inc