FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Biosensors Embolectomy Catheter
DI: 08888893235035
·
Model: EL 1580 (VP CAP)
·
BIOPTIMAL INTERNATIONAL PTE. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Biosensors Embolectomy Catheter
- Primary DI
- 08888893235035
- Version / Model
- EL 1580 (VP CAP)
- Catalog Number
- 23-000004-05
- Company Name
- BIOPTIMAL INTERNATIONAL PTE. LTD.
- Labeler DUNS
- 595182247
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 6
- Public Version Date
- 2022-10-24
- Public Version Status
- Update
- Public Device Record Key
- 5aaa15d3-ce3c-4ea1-9e15-5085bf544023
- Distribution End Date
- 2020-12-01
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
- Yes
- 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 |
|---|---|---|---|---|
| DXE | Catheter, Embolectomy | Cardiovascular | 870.5150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58174 | Thrombectomy balloon catheter | A flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) causing vascular obstruction in native and stented blood vessels, native and synthetic bypass grafts, and/or haemodialysis access grafts, through distension of a balloon intended to dilate the stenosis. It is a balloon catheter that may include valves for the injection of contrast media/thrombolytic agents and/or an embolectomy coil for mechanical removal of the obstruction. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 58888893235030 | GS1 | CTN | 30 | Not in Commercial Distribution | 2020-12-01 |
| Primary | 08888893235035 | GS1 |
Customer Contacts
- Phone
- +6562135777
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dark cool dry places