FDA.reportPublic FDA data

DF4 Helix Locking Tool

Primary DI
00810024671724
Brand
DF4 Helix Locking Tool
Company
CENTERPOINT SYSTEMS LLC
Model
A002HELX
Device description
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.
Published
2025-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810024671724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810024671724008100246717248100246717240810024671724

GMDN Terms#

Term, Definition table
TermDefinition
Torque manipulation deviceA sterile hand-operated device intended to be attached to the proximal end of an invasive device (e.g., a catheter, a needle, or a guidewire) to provide the operator with the ability to manually manipulate and control the directional torque (rotation) of the device to which it is attached. This device may be made of plastic or metal materials. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit54 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117126091
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810024671885CPS Locator 3D, Small Delivery CatheterDS2C100-42DS2C100-422026-07-13
00810024671892CPS Locator 3D, Medium Delivery CatheterDS2C200-422026-07-13
00810024671908CPS Locator 3D, Large Delivery CatheterDS2C300-42DS2C300-422026-07-13
00810024671915CPS Locator 3D, Medium, Extra Long Delivery CatheterDS2C200-45DS2C200-452026-07-13
00810024671922CPS Locator 3D, Large, Extra Long Delivery CatheterDS2C300-45DS2C300-452026-07-13
00810024671953SSPC NXT Delivery Catheter92932026-06-01
00810024672134CPS Locator 3D, BB1-36DS2CBB1-36DS2CBB1-362026-03-30
00810024672141CPS Locator 3D, BB1-40DS2CBB1-40DS2CBB1-402026-03-30
00810024671991AuST Steerable Sheath0-132H-H3574SAN0-SNSP02026-01-29
00810024672004AuST Steerable Sheath0-132H-H5074SAN0-SNSP02026-01-29
00810024670314AuST Steerable Sheath0-120H-H1774SAN5-SNSP02026-01-12
00810024670536AuST Steerable Sheath0-085H-H1774SAN0-SNSP02026-01-12
00810024670543AuST Steerable Sheath0-085H-H2274SAN0-SNSP02026-01-12
00810024670550AuST Steerable Sheath0-085H-H5074SAN0-SNSP02026-01-12
00810024671342AuST Steerable Sheath0-085H-H1744SAN0-SNSP02025-11-05
00810024671359AuST Steerable Sheath0-085H-H2244SAN0-SNSP02025-11-05
00810024671366AuST Steerable Sheath0-085H-H3544SAN0-SNSP02025-11-05
00810024671373AuST Steerable Sheath0-085H-H5044SAN0-SNSP02025-11-05
00810024671380AuST Steerable Sheath0-132H-H3544SAN0-SNSP02025-11-05
00810024671397AuST Steerable Sheath0-132H-H5044SAN0-SNSP02025-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776405830MillenniumAvalign Technologies, Inc.DWS2026-07-26
03661219438663DELACROIX-CHEVALIERLANDANGERDWS2026-07-25
00190776404222MillenniumAvalign Technologies, Inc.DWS2026-07-24
00190776405748MillenniumAvalign Technologies, Inc.DWS2026-07-24
00190776405779MillenniumAvalign Technologies, Inc.DWS2026-07-24
00190776403973MillenniumAvalign Technologies, Inc.DWS2026-07-22
00190776403348MillenniumAvalign Technologies, Inc.DWS2026-07-21
00190776403683MillenniumAvalign Technologies, Inc.DWS2026-07-21
00190776403768MillenniumAvalign Technologies, Inc.DWS2026-07-21
00190776400521MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776402051MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776402068MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776400309MillenniumAvalign Technologies, Inc.DWS2026-07-17
04058749009347NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749010060NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122671NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122725NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122794NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749125917NAFehling Instruments GmbH & Co. KGDWS2026-07-17
00190776397197MillenniumAvalign Technologies, Inc.DWS2026-07-16
00190776395643MillenniumAvalign Technologies, Inc.DWS2026-07-14
00190776396763MillenniumAvalign Technologies, Inc.DWS2026-07-14
03661219510970LANDANGERLANDANGERDWS2026-07-12
03661219512660DELACROIX-CHEVALIERLANDANGERDWS2026-07-12
03661219528371LANDANGERLANDANGERDWS2026-07-12
00850012846710ValveVaultLSI Solutions, Inc.DWS2026-07-08
03661219140238DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219141648DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219143482DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219317715DELACROIX-CHEVALIERLANDANGERDWS2026-07-08