FDA UDI
In Commercial Distribution
🇺🇸 United States
ACUITY™ X4 Spiral S
DI: 00802526524554
·
Model: 4674
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ACUITY™ X4 Spiral S
- Primary DI
- 00802526524554
- Version / Model
- 4674
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 106295384
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-02-25
- Public Version
- 6
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 9881e560-5e17-4572-baf1-15442e987887
Device Description
Pace/Sense Lead
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LWP | Implantable pulse generator, pacemaker (non-CRT) | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35223 | Endocardial pacing lead | An implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pulse generator to the heart; it is not intended to conduct defibrillation impulses. It may also transmit electrical responses from the heart back to the pacemaker. The electrode end is normally placed through a vein to contact the wall of one of the heart's chambers (endocardium), and the other end is connected to the pacemaker. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00802526524554 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P010012 | 395 |
| P010012 | 398 |
| P010012 | 416 |
| P010012 | 423 |
| P010012 | 437 |
| P010012 | 453 |
| P010012 | 484 |
| P010012 | 494 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 86 cm Length |