FDA UDI
In Commercial Distribution
🇺🇸 United States
VenaSeal™
DI: 00763000240776
·
Model: VS-404
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- VenaSeal™
- Primary DI
- 00763000240776
- Version / Model
- VS-404
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-08
- Public Version
- 5
- Public Version Date
- 2025-10-16
- Public Version Status
- Update
- Public Device Record Key
- e9f28edc-480f-4a42-a7d8-b5a93b49045b
Device Description
CLOSURE SYSTEM VS-404 VENASEAL US EA
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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PJQ | Agent, occluding, vascular, permanent | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58708 | Varicose vein adhesive-treatment kit | A collection of sterile devices intended to be used for the endovascular closure of the great saphenous vein (GSV) and associated varicosities as a treatment for varicose veins. It typically includes a surgical adhesive (e.g., cyanoacrylate), syringe, delivery catheter, dilator, introducer and a dispensing gun. The adhesive is typically delivered under ultrasonic control at prescribed intervals throughout the length of the affected vein to adhere the vessel walls together, resulting in the complete and permanent closure of the lumen. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000240776 | GS1 | ||||
| Package | 20763000240770 | GS1 | PK | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. VenaSeal system should be stored in its dispenser box carton at room temperature and humidity.