FDA UDI
In Commercial Distribution
🇺🇸 United States
Comet
DI: 08714729875758
·
Model: H7495551110
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Comet
- Primary DI
- 08714729875758
- Version / Model
- H7495551110
- 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
- 8c02264c-f4b5-4f40-84c2-5d090645dcf4
Device Description
Pressure Guidewire
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| DXO | TRANSDUCER, PRESSURE, CATHETER TIP | Cardiovascular | 870.2870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47486 | Intravascular haemodynamic monitoring system guidewire | A sterile, steerable, component of a haemodynamics monitoring system for the in vivo measurement of blood pressure and/or blood flow velocity in all blood vessels, including the coronary and peripheral arteries, during diagnostic and/or interventional procedures. It typically consists of a long, thin, flexible rod that has built-in pressure/flow measuring transducers/sensors at its working end, and a torque device to facilitate navigation through the vasculature; it has a handle at the proximal end and a cable(s) to connect to the monitoring system. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08714729875758 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 185 cm Effective Length | ||
| Device Size Text, specify | 0.014 in Diameter |