FDA UDI
In Commercial Distribution
🇺🇸 United States
Pounce Venous Thrombectomy System
DI: 00812339030319
·
Model: VTS-0018-09010
·
Surmodics, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pounce Venous Thrombectomy System
- Primary DI
- 00812339030319
- Version / Model
- VTS-0018-09010
- Company Name
- Surmodics, Inc.
- Labeler DUNS
- 098414659
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-27
- Public Version
- 1
- Public Version Date
- 2023-11-06
- Public Version Status
- New
- Public Device Record Key
- f2df7707-c6a5-4ae4-ac92-e5943fe7e652
Device Description
Pounce Venous Thrombectomy System
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 |
|---|---|---|---|---|
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | Cardiovascular | 870.5150 | 2 |
| KRA | Catheter, Continuous Flush | Cardiovascular | 870.1210 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58172 | Thrombectomy rotational catheter | A sterile flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) causing acute vascular obstruction in native and stented blood vessels, or in native and synthetic bypass or haemodialysis access grafts, through a mechanical rotational action intended to erode and aspirate the obstruction for removal. It typically consists of a rotational catheter body/head powered by a magnetic power transmission provided by a connected control unit; ancillary device such as catheter guidewires, sterile cable covers, and collecting bags may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812339030319 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Length | 90 | Centimeter | |
| Device Size Text, specify | Adjustable basket diameter range 6-16 mm |