ULTRASCORE
- Primary DI
- 00801741113352
- Brand
- ULTRASCORE
- Company
- Bard Peripheral Vascular, Inc.
- Model
- US14150230
- Catalog number
- US14150230
- Device description
- ULTRASCORE™ Focused Force PTA Balloon 2mm x 300mm, 150cm catheter
- Published
- 2019-03-04
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Contact Domains
crbard.comProduct Codes
| Code | Name |
|---|---|
| PNO | Catheter, percutaneous, cutting/scoring |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| PNO | Catheter, Percutaneous, Cutting/Scoring | Cardiovascular | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00801741113352 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00801741113352 | 00801741113352 | 801741113352 | 0801741113352 |
GMDN Terms
| Term | Definition |
|---|---|
| Peripheral angioplasty balloon catheter, basic | A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +1(800)321-4254 | medical.services@crbard.com |
Regulatory Flags
- DUNS number
- 135057938
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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| 00801741234262 | EnCor EnCompass™ | ENCPFS | ENCPFS | 2026-02-03 |
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| 10801741234139 | EnCor EnCompass™ | ENCP7GBT | ENCP7GBT | 2026-01-30 |
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| 10801741234115 | EnCor EnCompass™ | ENCP12G | ENCP12G | 2026-01-28 |
| 10801741234146 | EnCor EnCompass™ | ENCP10GBT | ENCP10GBT | 2026-01-28 |
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| 10801741226332 | UltraCor™ Twirl™ | UCLS17 | UCLS17 | 2025-04-01 |
| 10801741226349 | UltraCor™ Twirl™ | UCVR17 | UCVR17 | 2025-04-01 |
| 10801741230605 | PeritX | 90-2010 | 90-2010 | 2025-01-23 |
| 10801741230612 | PeritX | 90-2005 | 90-2005 | 2025-01-23 |
| 10801741230636 | PeritX | 90-2020 | 90-2020 | 2025-01-23 |
| 50885403464032 | Jamshidi | EJC3513 | EJC3513 | 2017-10-02 |
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