FDA UDI
In Commercial Distribution
🇺🇸 United States
LUTONIX® Drug Coated Balloon
DI: 00801741199226
·
Model: LX1815041004F
·
LUTONIX, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- LUTONIX® Drug Coated Balloon
- Primary DI
- 00801741199226
- Version / Model
- LX1815041004F
- Catalog Number
- LX1815041004F
- Company Name
- LUTONIX, INC.
- Labeler DUNS
- 946734808
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-09
- Public Version
- 1
- Public Version Date
- 2019-09-17
- Public Version Status
- New
- Public Device Record Key
- 954b01e0-38f0-4277-84a5-a835267791a6
Device Description
Lutonix 018 4X100MMX150CM
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ONU | Drug-Eluting Peripheral Transluminal Angioplasty Catheter | Unknown | 3 | |
| PRC | Drug-coated peripheral transluminal angioplasty catheter | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62551 | Peripheral angioplasty balloon catheter, drug-coated | A sterile, 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, and to simultaneously release a drug intended to inhibit restenosis; 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. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00801741199226 | GS1 |
Customer Contacts
- Phone
- +1(800)321-4254
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Balloon Diameter, 4 millimeter | ||
| Device Size Text, specify | Balloon Length, 100 millimeter | ||
| Device Size Text, specify | Catheter Length, 150 centimeter |