FDA UDI
In Commercial Distribution
🇺🇸 United States
DF4 Helix Locking Tool
DI: 00810024671724
·
Model: A002HELX
·
CENTERPOINT SYSTEMS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DF4 Helix Locking Tool
- Primary DI
- 00810024671724
- Version / Model
- A002HELX
- Company Name
- CENTERPOINT SYSTEMS LLC
- Labeler DUNS
- 117126091
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-03
- Public Version
- 1
- Public Version Date
- 2025-12-11
- Public Version Status
- New
- Public Device Record Key
- abb3c1a6-847c-45fa-875f-8e9b59bc112b
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | 870.4500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46455 | Torque manipulation device | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810024671724 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 54 Degrees Fahrenheit