FDA UDI
In Commercial Distribution
🇺🇸 United States
Diamondback Coronary
DI: 10852528005336
·
Model: DBEC-125M
·
Cardiovascular Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Diamondback Coronary
- Primary DI
- 10852528005336
- Version / Model
- DBEC-125M
- Catalog Number
- 7-10000-01
- Company Name
- Cardiovascular Systems, Inc.
- Labeler DUNS
- 024954518
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-04
- Public Version
- 5
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- 435ad1bf-3273-4423-b903-6f9b3ee6daa4
Device Description
DIAMONDBACK 360® Coronary Orbital Atherectomy System, Micro Crown
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
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 | 10852528005336 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Intro sheath 6Fr | ||
| Device Size Text, specify | Max OD 0.052 in | ||
| Device Size Text, specify | High speed 80 krpm | ||
| Device Size Text, specify | Low speed 50 krpm | ||
| Device Size Text, specify | Guidewire size OD 0.012 in | ||
| Device Size Text, specify | Shaft length 135cm | ||
| Device Size Text, specify | Nose length 7mm | ||
| Device Size Text, specify | Crown Diamter 1.25mm |