RotaWire™ and wireClip™ Torquer
- Primary DI
- 08714729185871
- Brand
- RotaWire™ and wireClip™ Torquer
- Company
- BOSTON SCIENTIFIC CORPORATION
- Model
- H802228240020
- Catalog number
- H802228240020
- Device description
- Guidewire and Guidewire Manipulation Device
- Published
- 2014-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| MCX | CATHETER, CORONARY, ATHERECTOMY |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| MCX | Catheter, Coronary, Atherectomy | Unknown | 3 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| 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 |
| P900056 | 139 |
| P900056 | 221 |
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| P900056 | 000 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 008 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 009 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 010 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 011 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 012 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 014 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 015 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 017 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 018 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 019 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 020 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 021 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 022 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 023 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 025 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 027 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 029 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 036 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 037 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 041 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 047 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 049 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 052 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 062 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 066 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 067 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 068 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 078 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 083 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 090 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 094 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 104 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 106 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 107 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 139 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 221 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08714729195566 | Package | GS1 | 5 | In Commercial Distribution |
| 08714729185871 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08714729195566 | 08714729195566 | 8714729195566 |
| 08714729185871 | 08714729185871 | 8714729185871 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 |
Regulatory Flags#
- DUNS number
- 021717889
- Device count
- 1
- Kit
- true
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 08714729142201 | EndoVive Low Profile Replacement Button | M00562770 | 2016-09-24 | |
| 08714729142218 | EndoVive Low Profile Replacement Button | M00562830 | 2016-09-24 | |
| 08714729149200 | EndoVive™ One Step Button™ | M00568450 | M00568450 | 2018-09-07 |
| 08714729149217 | EndoVive™ One Step Button™ | M00568470 | M00568470 | 2018-09-07 |
| 08714729149224 | EndoVive™ One Step Button™ | M00568500 | M00568500 | 2018-09-07 |
| 08714729149231 | EndoVive™ One Step Button™ | M00568520 | M00568520 | 2018-09-07 |
| 08714729149934 | EndoVive™ One Step Button™ | M00568480 | M00568480 | 2018-09-07 |
| 08714729149941 | EndoVive™ One Step Button™ | M00568530 | M00568530 | 2018-09-07 |
| 08714729150084 | EndoVive™ One Step Button™ | M00568460 | M00568460 | 2018-09-07 |
| 08714729151081 | EndoVive™ One Step Button™ | M00568510 | M00568510 | 2018-09-07 |
| 08714729284017 | EndoVive Low Profile Replacement Button | M00562760 | 2016-09-24 | |
| 08714729284024 | EndoVive Low Profile Replacement Button | M00562780 | 2016-09-24 | |
| 08714729284031 | EndoVive Low Profile Replacement Button | M00562790 | 2016-09-24 | |
| 08714729284048 | EndoVive Low Profile Replacement Button | M00562800 | 2016-09-24 | |
| 08714729284062 | EndoVive Low Profile Replacement Button | M00562820 | 2016-09-24 | |
| 08714729284079 | EndoVive Low Profile Replacement Button | M00562840 | 2016-09-24 | |
| 08714729284086 | EndoVive Low Profile Replacement Button | M00562850 | 2016-09-24 | |
| 08714729821717 | Radial Jaw 4 | M00515180 | 2016-09-24 | |
| 08714729821731 | Radial Jaw 4 | M00515190 | 2016-09-24 | |
| 08714729821748 | Radial Jaw 4 | M00515200 | 2016-09-24 |
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