Ultraverse® 018
- Primary DI
- 00801741055003
- Brand
- Ultraverse® 018
- Company
- Bard Peripheral Vascular, Inc.
- Model
- U813048
- Catalog number
- U813048
- Device description
- Ultraverse® 018 PTA Balloon Dilatation Catheter 4 mm x 80 mm, 130 cm Catheter
- Published
- 2016-07-15
- 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 |
|---|---|
| LIT | Catheter, angioplasty, peripheral, transluminal |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00801741055003 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00801741055003 | 00801741055003 | 801741055003 | 0801741055003 |
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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| 10801741226332 | UltraCor™ Twirl™ | UCLS17 | UCLS17 | 2025-04-01 |
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| 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 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 07640119558639 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558646 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558653 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558660 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558677 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558684 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558691 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558707 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558714 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558721 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558738 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558745 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558752 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558769 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558776 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558783 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558790 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558806 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558813 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558820 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558837 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558844 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558851 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558868 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558875 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558882 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558899 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558905 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558912 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558929 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |