ULTRASCORE
- Primary DI
- 00801741113536
- Brand
- ULTRASCORE
- Company
- Bard Peripheral Vascular, Inc.
- Model
- US14150320
- Catalog number
- US14150320
- Device description
- ULTRASCORE™ Focused Force PTA Balloon 3mm x 200mm, 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
- Sterile
- true
- Single use
- true
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 |
|---|---|---|---|---|
| 00801741113536 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00801741113536 | 00801741113536 | 801741113536 | 0801741113536 |
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 | |
| Device Size Text, specify | 0 | |
| 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
- Lot or batch
- true
- Expiration date on label
- true
- No natural rubber latex
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10801741234184 | EnCor EnCompass™ | ENCPBag | ENCPBag | 2026-02-09 |
| 00801741234187 | EnCor EnCompass™ | ENCPBag | ENCPBag | 2026-02-09 |
| 00801741234156 | EnCor EnCompass™ | ENCPSC | ENCPSC | 2026-02-04 |
| 00801741234163 | EnCor EnCompass™ | ENCPMRIX | ENCPMRIX | 2026-02-04 |
| 10801741234153 | EnCor EnCompass™ | ENCPSC | ENCPSC | 2026-02-04 |
| 10801741234160 | EnCor EnCompass™ | ENCPMRIX | ENCPMRIX | 2026-02-04 |
| 00801741236167 | EnCor EnCompass™ | ENCP10GVLOC | ENCP10GVLOC | 2026-02-04 |
| 00801741234194 | EnCor EnCompass™ | ENCPST | ENCPST | 2026-02-03 |
| 00801741234248 | EnCor EnCompass™ | ENCPDriver | ENCPDriver | 2026-02-03 |
| 00801741234262 | EnCor EnCompass™ | ENCPFS | ENCPFS | 2026-02-03 |
| 00801741235221 | EnCor EnCompass™ | ENCPConsole | ENCPConsole | 2026-02-03 |
| 00801741234095 | EnCor EnCompass™ | ENCP7G | ENCP7G | 2026-01-30 |
| 00801741234132 | EnCor EnCompass™ | ENCP7GBT | ENCP7GBT | 2026-01-30 |
| 10801741234092 | EnCor EnCompass™ | ENCP7G | ENCP7G | 2026-01-30 |
| 10801741234139 | EnCor EnCompass™ | ENCP7GBT | ENCP7GBT | 2026-01-30 |
| 00801741234200 | EnCor EnCompass™ | ENCP7GVLOC | ENCP7GVLOC | 2026-01-30 |
| 00801741234118 | EnCor EnCompass™ | ENCP12G | ENCP12G | 2026-01-28 |
| 00801741234149 | EnCor EnCompass™ | ENCP10GBT | ENCP10GBT | 2026-01-28 |
| 00801741234170 | EnCor EnCompass™ | ENCP10G | ENCP10G | 2026-01-28 |
| 10801741234115 | EnCor EnCompass™ | ENCP12G | ENCP12G | 2026-01-28 |
Other Devices Sharing Product Codes#
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|---|---|---|---|---|
| 06923533801057 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-05-15 |
| B090XC2201450 | XO Constrain | ZIEN MEDICAL TECHNOLOGIES, INC. | PNO | 2026-02-03 |
| B090XC2201451 | XO Constrain | ZIEN MEDICAL TECHNOLOGIES, INC. | PNO | 2026-02-03 |
| 06972253606060 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-30 |
| 06972253606084 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-30 |
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