Woven
- Primary DI
- 08714729901433
- Brand
- Woven
- Company
- BOSTON SCIENTIFIC CORPORATION
- Model
- M0046FMC006580
- Device description
- Diagnostic Electrode 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 |
|---|---|
| DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08714729901433 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08714729901433 | 08714729901433 | 8714729901433 |
GMDN Terms
| Term | Definition |
|---|---|
| Cardiac mapping catheter, percutaneous, single-use | A sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias, cardioversion (CV) of electrical arrhythmias or electrophysiology (EP) mapping of cardiac structures. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 021717889
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- 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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|---|---|---|---|---|
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| 08714729195566 | RotaWire™ and wireClip™ Torquer | H802228240020 | H802228240020 | 2014-09-24 |
| 08714729837527 | Stingray™ | H749M3004A0 | 2016-09-24 | |
| 08714729877523 | EP XT™ | M0042007720 | M0042007720 | 2016-09-24 |
| 08714729877714 | Dynamic XT™ | M0042011120 | M0042011120 | 2016-09-24 |
| 08714729879947 | EP XT™ | M0046EPXT00390 | M0046EPXT00390 | 2016-09-24 |
| 08714729181088 | Percuflex™ Biliary | M00533760 | 2015-09-24 | |
| 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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