NA
- Primary DI
- 00802526489334
- Brand
- NA
- Company
- BOSTON SCIENTIFIC CORPORATION
- Model
- 6584
- Device description
- J-shaped Lead Stylet Firm
- Published
- 2015-09-24
- 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 |
|---|---|
| DTD | pacemaker lead Adaptor |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| DTD | Pacemaker Lead Adaptor | Cardiovascular | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00802526489334 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00802526489334 | 00802526489334 | 802526489334 | 0802526489334 |
GMDN Terms
| Term | Definition |
|---|---|
| Pacing/defibrillation lead stylet | A sterile wire, intended to be percutaneously inserted into the coronary venous vasculature to aid in the transvenous placement and/or removal of implantable pacemaker/defibrillator leads; it may in addition be intended to extract an indwelling catheter or other foreign object. It is manipulated proximally with a handle, and its working end is typically made of extremely thin stainless steel wire (e.g., 0.4 mm to 0.81 mm in diameter), and may be available in various wire lengths and degrees of rigidity. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 106295384
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- 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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| 08714729181101 | Percuflex™ Biliary | M00533780 | 2015-09-24 | |
| 08714729181118 | Percuflex™ Biliary | M00533790 | 2015-09-24 | |
| 08714729181125 | Percuflex™ Biliary | M00533800 | 2015-09-24 | |
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| 00763000059460 | NA | MEDTRONIC, INC. | DTD | 2019-05-11 |
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| 00836559002611 | C/IS-10 | Oscor Inc. | DTD | 2015-10-16 |
| 00836559002642 | M/IS-40 | Oscor Inc. | DTD | 2015-10-16 |
| 00836559002666 | B/IS-15 | Oscor Inc. | DTD | 2015-10-16 |
| 00836559002680 | BIS/IS-15 | Oscor Inc. | DTD | 2015-10-16 |