FDA UDI
In Commercial Distribution
🇺🇸 United States
SET Aspirex™ S 10F 110cm
DI: 07640142811350
·
Model: 80328
·
Straub Medical AG
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SET Aspirex™ S 10F 110cm
- Primary DI
- 07640142811350
- Version / Model
- 80328
- Catalog Number
- 80328
- Company Name
- Straub Medical AG
- Labeler DUNS
- 488489766
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-30
- Public Version
- 4
- Public Version Date
- 2025-04-25
- Public Version Status
- Update
- Public Device Record Key
- e121d787-1ab8-4cb1-88e0-4082b4e25be7
Device Description
The Aspirex™ Thrombectomy Catheter Set is composed of one Aspirex™ Thrombectomy Catheter (gauge 10F; length 110cm), one Aspirex™ Guidewire (0.025” diameter; 270cm in length), one collecting bag, and one sterile drape.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- 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 |
| DQX | Wire, Guide, Catheter | Cardiovascular | 870.1330 | 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 | 07640142811350 | GS1 |
Customer Contacts
- Phone
- +1(800)321-4254
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 10 | French | |
| Catheter Working Length | 110 | Centimeter |