FDA UDI
In Commercial Distribution
🇺🇸 United States
RotaWire™ Drive and wireClip™ Torquer
DI: 08714729996231
·
Model: H74939463001
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- RotaWire™ Drive and wireClip™ Torquer
- Primary DI
- 08714729996231
- Version / Model
- H74939463001
- Catalog Number
- H74939463001
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-15
- Public Version
- 1
- Public Version Date
- 2021-02-23
- Public Version Status
- New
- Public Device Record Key
- cbcf3f02-0227-4035-8754-5b14418d912e
Device Description
Guidewire and Guidewire Manipulation 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 |
|---|---|---|---|---|
| MCX | CATHETER, CORONARY, ATHERECTOMY | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35094 | Cardiac/peripheral vascular guidewire, single-use | A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08714729996248 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 08714729996231 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P900056 | 183 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Guidewire Length | 330 | Centimeter | |
| Guidewire Diameter | 0.009 | Inch |