FDA UDI
Not in Commercial Distribution
🇺🇸 United States
TruePath™
DI: 08714729820284
·
Model: H74939208181650
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TruePath™
- Primary DI
- 08714729820284
- Version / Model
- H74939208181650
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2023-11-21
- Public Version Status
- Update
- Public Device Record Key
- cbef1650-739a-41eb-a80b-2204a801d609
- Distribution End Date
- 2020-05-13
Device Description
CTO Device
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 |
|---|---|---|---|---|
| PDU | Catheter for crossing total occlusions | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61600 | Peripheral vascular guidewire, powered | A sterile, battery–powered wire with a rotational cutting tip intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to create a pathway through a chronic vascular obstruction [e.g., a chronic total occlusion (CTO)], and to function as a guide for the introduction of another device (e.g., manual guidewire, catheter). It consists of a long, thin, shapeable/steerable wire and a detachable battery-powered motor/control unit; it is typically used under fluoroscopic guidance. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08714729820284 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 0.018 in Diameter | ||
| Device Size Text, specify | 165 cm Effective Length |