FDA UDI
In Commercial Distribution
🇺🇸 United States
RotaLink™ Burr
DI: 08714729185840
·
Model: H802227680040
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RotaLink™ Burr
- Primary DI
- 08714729185840
- Version / Model
- H802227680040
- Catalog Number
- H802227680040
- 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
- 5
- Public Version Date
- 2021-04-06
- Public Version Status
- Update
- Public Device Record Key
- e605f09f-cb65-491e-be40-d56f4cd52fae
Device Description
Exchangeable Burr Catheter
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 | 08714729185840 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P900056 | 000 |
| P900056 | 001 |
| P900056 | 002 |
| P900056 | 003 |
| P900056 | 004 |
| P900056 | 005 |
| P900056 | 006 |
| P900056 | 008 |
| P900056 | 009 |
| P900056 | 010 |
| P900056 | 011 |
| P900056 | 012 |
| P900056 | 014 |
| P900056 | 015 |
| P900056 | 017 |
| P900056 | 018 |
| P900056 | 020 |
| P900056 | 021 |
| P900056 | 023 |
| P900056 | 027 |
| P900056 | 029 |
| P900056 | 036 |
| P900056 | 037 |
| P900056 | 043 |
| P900056 | 048 |
| P900056 | 049 |
| P900056 | 056 |
| P900056 | 060 |
| P900056 | 065 |
| P900056 | 066 |
| P900056 | 067 |
| P900056 | 083 |
| P900056 | 084 |
| P900056 | 092 |
| P900056 | 094 |
| P900056 | 101 |
| P900056 | 104 |
| P900056 | 107 |
| P900056 | 139 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 0.069 in Diameter | ||
| Device Size Text, specify | 1.75 mm Diameter |