OptiCross 18
- Primary DI
- 08714729904366
- Brand
- OptiCross 18
- Company
- BOSTON SCIENTIFIC CORPORATION
- Model
- H7493932800180
- Device description
- Peripheral Imaging Catheter
- Published
- 2016-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| OBJ | Catheter, ultrasound, intravascular |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| OBJ | Catheter, Ultrasound, Intravascular | Cardiovascular | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08714729904366 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08714729904366 | 08714729904366 | 8714729904366 |
GMDN Terms
| Term | Definition |
|---|---|
| Intravascular ultrasound imaging catheter, single-use | A flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary artery) by an operator; it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer, it includes either a single or an array of transducer element(s) (piezoelectric, active, or crystal); it cannot be manoeuvred via controls (i.e., non-steerable). This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 021717889
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 08714729181095 | Percuflex™ Biliary | M00533770 | 2015-09-24 | |
| 08714729181101 | Percuflex™ Biliary | M00533780 | 2015-09-24 | |
| 08714729181118 | Percuflex™ Biliary | M00533790 | 2015-09-24 | |
| 08714729181125 | Percuflex™ Biliary | M00533800 | 2015-09-24 | |
| 08714729181132 | Percuflex™ Biliary | M00533810 | 2015-09-24 | |
| 08714729181149 | Percuflex™ Biliary | M00533820 | 2015-09-24 | |
| 08714729181156 | Percuflex™ Biliary | M00533830 | 2015-09-24 | |
| 08714729181163 | Percuflex™ Biliary | M00533850 | 2015-09-24 | |
| 08714729181217 | Percuflex™ Biliary | M00533610 | 2015-09-24 | |
| 08714729181224 | Percuflex™ Biliary | M00533620 | 2015-09-24 | |
| 08714729181231 | Percuflex™ Biliary | M00533630 | 2015-09-24 | |
| 08714729181248 | Percuflex™ Biliary | M00533640 | 2015-09-24 | |
| 08714729181255 | Percuflex™ Biliary | M00533650 | 2015-09-24 |
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