FDA UDI
In Commercial Distribution
🇺🇸 United States
wireClip™ Torquer
DI: 08714729154785
·
Model: H802221960030
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- wireClip™ Torquer
- Primary DI
- 08714729154785
- Version / Model
- H802221960030
- Catalog Number
- H802221960030
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- a73c5200-0a84-4c8a-936f-169ad0147a6f
Device Description
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 | 08714729195535 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 08714729154785 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P900056 | 000 |
| P900056 | 008 |
| P900056 | 009 |
| P900056 | 010 |
| P900056 | 011 |
| P900056 | 012 |
| P900056 | 014 |
| P900056 | 015 |
| P900056 | 017 |
| P900056 | 018 |
| P900056 | 019 |
| P900056 | 020 |
| P900056 | 021 |
| P900056 | 022 |
| P900056 | 023 |
| P900056 | 025 |
| P900056 | 027 |
| P900056 | 029 |
| P900056 | 036 |
| P900056 | 037 |
| P900056 | 041 |
| P900056 | 047 |
| P900056 | 049 |
| P900056 | 052 |
| P900056 | 062 |
| P900056 | 066 |
| P900056 | 067 |
| P900056 | 068 |
| P900056 | 078 |
| P900056 | 083 |
| P900056 | 090 |
| P900056 | 094 |
| P900056 | 104 |
| P900056 | 106 |
| P900056 | 107 |