Identity
- Trade Name
- Vascular Solutions Custom Access Kit FDA UDI
- Generic Name
- Varicose vein lasing procedure kit FDA UDI
- Device Name
- The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following a needle stick. FDA UDI
- Model / Reference
- 7718 FDA UDI
- Description
- The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following a needle stick. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M20677181 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Varicose vein lasing procedure kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 19 Gauge FDA UDI
Vascular Solutions Custom Access Kit by Vascular Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Vascular Solutions, Inc.
Sources (1)
- FDA UDI a8a723cf-900e-4fd0-bad6-2036ca3fddf6 36 fields · synced Jun 8, 2026