FDA UDI
Not in Commercial Distribution
🇺🇸 United States
JETi Thrombectomy System, Sterile Disposable Components Kit, 6 Fr
DI: B139WV62031
·
Model: WV6203
·
WALK VASCULAR L.L.C.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- JETi Thrombectomy System, Sterile Disposable Components Kit, 6 Fr
- Primary DI
- B139WV62031
- Version / Model
- WV6203
- Company Name
- WALK VASCULAR L.L.C.
- Labeler DUNS
- 034774488
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-17
- Public Version
- 3
- Public Version Date
- 2022-09-27
- Public Version Status
- Update
- Public Device Record Key
- 42b08f93-bfdf-41c4-bba0-93915f380c51
- Distribution End Date
- 2021-10-15
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
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36142 | Aspiration tray, single-use | A container of various instruments, dressings, pharmaceuticals, and other items necessary to perform an aspiration and related procedures. It typically includes separate sections designated to hold the various utensils required for needle biopsy, aspiration, and/or drainage. Its bottom typically has a plastic foam insert that is scored to allow placement of sharp objects and needles. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B139WV62031 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Working Length | 120 | Centimeter | |
| Catheter Gauge | 6 | French |