FDA UDI
In Commercial Distribution
🇺🇸 United States
IntellaTip MiFi™ Open-Irrigated
DI: 08714729848684
·
Model: M004PM96200
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IntellaTip MiFi™ Open-Irrigated
- Primary DI
- 08714729848684
- Version / Model
- M004PM96200
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-13
- Public Version
- 8
- Public Version Date
- 2023-02-08
- Public Version Status
- Update
- Public Device Record Key
- 4c70f640-0078-46d6-a96f-31e52611cddf
Device Description
Ablation Catheter
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 |
|---|---|---|---|---|
| OAD | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61785 | Cardiac radio-frequency ablation system catheter | A sterile, flexible, steerable catheter intended to be used as part of a radio-frequency cardiac ablation system to apply radio-frequency alternating current to ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias; it is typically also intended to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and may contain monopolar and/or bipolar ablation electrodes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08714729848684 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P150005 | 008 |
| P150005 | 020 |
| P150005 | 035 |
| P150005 | 045 |
| P150005 | 047 |
| P150005 | 061 |
| P150005 | 072 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 4.5 mm Length | ||
| Device Size Text, specify | 7.5 F Diameter | ||
| Device Size Text, specify | 2.50 mm Length |