FDA UDI
In Commercial Distribution
🇺🇸 United States
Selethru NC PTCA Balloon Dilatation Catheter
DI: 06971591765675
·
Model: KNC225010
·
Kossel Medtech (Suzhou) Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Selethru NC PTCA Balloon Dilatation Catheter
- Primary DI
- 06971591765675
- Version / Model
- KNC225010
- Company Name
- Kossel Medtech (Suzhou) Co., Ltd.
- Labeler DUNS
- 560219894
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-20
- Public Version
- 1
- Public Version Date
- 2021-09-28
- Public Version Status
- New
- Public Device Record Key
- 6d68d36f-f103-4276-8946-e9773391247d
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 |
|---|---|---|---|---|
| LOC | System, Rf/Microwave Hyperthermia, Cancer Treatment | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17521 | Coronary angioplasty balloon catheter, perfusing | A sterile, flexible tube designed for use in percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon. The tube contains holes proximal and distal to the balloon that permit blood flow to the distal coronary arteries during balloon dilatation to protect the myocardium from haemodynamic compromise. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06971591765675 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211393 | 000 |