FDA UDI
In Commercial Distribution
🇺🇸 United States
Viking™ Soft Tip
DI: 08714729879374
·
Model: M0044005380
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Viking™ Soft Tip
- Primary DI
- 08714729879374
- Version / Model
- M0044005380
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- eefe7edd-d7f5-4c44-a0fc-8bac0e5c8c1a
Device Description
Fixed Curve Diagnostic 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 |
|---|---|---|---|---|
| DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | Cardiovascular | 870.1220 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16995 | Intracardiac electrode | An electrical conductor designed for measuring the electrical activity of and/or to provide pacing signals to the interior of the heart; some electrodes are used to provide electric (e.g., radio-frequency) energy to ablate cardiac tissue. It is usually a very small electrode capable of detecting weak bioelectrical signals and/or to provide high electrical energy; it is typically located at or near the tip of cardiac [e.g., electrophysiology (EP), pacing, ablation] catheters. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08714729879374 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 10 mm Length | ||
| Device Size Text, specify | 2.00 mm Diameter | ||
| Device Size Text, specify | 6 F Diameter |