DEVICE: RotaWire™ and wireClip™ Torquer (08714729185871)
Device Identifier (DI) Information
RotaWire™ and wireClip™ Torquer
H802228240020
In Commercial Distribution
H802228240020
BOSTON SCIENTIFIC CORPORATION
H802228240020
In Commercial Distribution
H802228240020
BOSTON SCIENTIFIC CORPORATION
Guidewire and Guidewire Manipulation Device
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| Yes | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| MCX | CATHETER, CORONARY, ATHERECTOMY |
FDA Premarket Submission
| FDA Premarket 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 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: 0.009 in Diameter |
| Device Size Text, specify: 330 cm Length |
Device Record Status
38ce36fb-ada3-47fa-b9a4-5fa61c0eca81
July 06, 2018
3
September 24, 2014
July 06, 2018
3
September 24, 2014
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 08714729195566 | 5 | 08714729185871 | In Commercial Distribution |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined