FDA UDI
In Commercial Distribution
🇺🇸 United States
Electrophysiology Cable
DI: 08714729861874
·
Model: M0046610
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Electrophysiology Cable
- Primary DI
- 08714729861874
- Version / Model
- M0046610
- Catalog Number
- M0046610
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-01-27
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 9dd04eda-d3b5-4ebb-823e-d6a6141b9e8a
Device Description
CONTROLLER TO PUMP OR REMOTE CONTROL
Device Characteristics
- Single Use
- No
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OAD | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47249 | Cardiac ablation system cable, reusable | An insulated electrical conductor used to provide an electrical connection between a cardiac tissue ablation system generator and the operative ablative device (e.g., a dedicated cardiac tissue ablation system applicator or a catheter). Its length may also allow the operative ablative device to remain in the sterile field. The electrical conductor is typically made of robust materials with metal connectors [e.g., gold (Au) plated electrical connecting pins and sockets] for reliability. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08714729861874 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P020025 | 060 |
| P920047 | 072 |
| P980003 | 052 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 610 cm Length |