FDA UDI
In Commercial Distribution
🇺🇸 United States
Recanalization System
DI: 00801741202452
·
Model: BDRECANSYSTEMS
·
Bard Peripheral Vascular, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Recanalization System
- Primary DI
- 00801741202452
- Version / Model
- BDRECANSYSTEMS
- Catalog Number
- BDRECANSYSTEMS
- Company Name
- Bard Peripheral Vascular, Inc.
- Labeler DUNS
- 135057938
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-30
- Public Version
- 1
- Public Version Date
- 2022-04-07
- Public Version Status
- New
- Public Device Record Key
- d6134ba7-07ef-4556-8e27-a0b7f98b8131
Device Description
Recanalization System, Serviced
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PDU | Catheter for crossing total occlusions | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33854 | Mechanical atherectomy system generator, electrical output | A mains electricity (AC-powered) component of a mechanical atherectomy system designed to generate a high frequency electrical current that is converted via a separate transducer, typically within a handpiece, into vibrational energy for the fragmentation of a chronic partial occlusion (CPO) or chronic total occlusion (CTO) of both coronary and peripheral arteries during an atherectomy procedure. The device may be operated via a foot-switch and may include an integrated suction/aspiration system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00801741202452 | GS1 |
Customer Contacts
- Phone
- +1(800)562-0027
- [email protected]