FDA UDI
In Commercial Distribution
🇺🇸 United States
Sublime™ 014 Rx PTA Balloon Dilatation Catheter
DI: 05391525783697
·
Model: SRA-DC14-25020
·
CREAGH MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sublime™ 014 Rx PTA Balloon Dilatation Catheter
- Primary DI
- 05391525783697
- Version / Model
- SRA-DC14-25020
- Company Name
- CREAGH MEDICAL LIMITED
- Labeler DUNS
- 985021909
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-08
- Public Version
- 1
- Public Version Date
- 2021-03-16
- Public Version Status
- New
- Public Device Record Key
- e0bb0545-f2e6-49fd-b629-fd6a1deb18d0
Device Description
014 Radial Catheter 2.5mm x 20mm x 250cm
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17184 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05391525783697 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200700 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Balloon Diameter | 2.5 | Millimeter | |
| Balloon Length | 20 | Micrometer | |
| Catheter Length | 250 | Centimeter | |
| Device Size Text, specify | Guidewire comtability 0.014inch |