FDA UDI
In Commercial Distribution
🇺🇸 United States
ROTAPRO™
DI: 08714729999638
·
Model: H749394672500
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ROTAPRO™
- Primary DI
- 08714729999638
- Version / Model
- H749394672500
- Catalog Number
- H749394672500
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-01
- Public Version
- 2
- Public Version Date
- 2021-04-06
- Public Version Status
- Update
- Public Device Record Key
- 9aac71e0-9986-41aa-938b-628907d071f9
Device Description
Pre-Connected Exchangeable Burr Catheter and Burr Advancing 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 |
|---|---|---|---|---|
| 61205 | Mechanical atherectomy system, coronary, line-powered | An assembly of devices intended to mechanically disrupt/remove atheroma plaque from the walls of coronary arteries. It typically includes a mains electricity (AC-powered) energy-producing generator with monitoring functions, a remote control or foot-switch, a handpiece (to which the catheter connects) and a dedicated disposable catheter with a cutting or abrasive head that transmits the mechanical energy to the atheroma. The system may include an integrated irrigation/suction system and includes/requires accessory devices for its function (e.g., saline/lubricant, pump, guidewire). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08714729999638 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P900056 | 181 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Guidewire Diameter | 2.50 | Millimeter |