FDA UDI
In Commercial Distribution
🇺🇸 United States
Electrophysiology Cable
DI: 08714729347897
·
Model: M004620620
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Electrophysiology Cable
- Primary DI
- 08714729347897
- Version / Model
- M004620620
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 4
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 62209a05-e623-4a97-af59-4c43c6ea5928
Device Description
Sterile Cable
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
- 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
- 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 |
|---|---|---|---|---|
| LPB | Cardiac ablation percutaneous catheter | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47143 | Electrical-only medical device connection cable, single-use | A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08714729347897 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P980003 | 000 |
| P980003 | 001 |
| P980003 | 002 |
| P980003 | 004 |
| P980003 | 005 |
| P980003 | 007 |
| P980003 | 008 |
| P980003 | 009 |
| P980003 | 010 |
| P980003 | 013 |
| P980003 | 015 |
| P980003 | 016 |
| P980003 | 018 |
| P980003 | 019 |
| P980003 | 020 |
| P980003 | 021 |
| P980003 | 025 |
| P980003 | 027 |
| P980003 | 030 |
| P980003 | 031 |
| P980003 | 034 |
| P980003 | 038 |
| P980003 | 041 |
| P980003 | 045 |
| P980003 | 050 |
| P980003 | 052 |
| P980003 | 053 |
| P980003 | 056 |
| P980003 | 061 |