Identity
- Trade Name
- Nephrostomy introduction Needle Bevel Tip FDA UDI
- Generic Name
- Vascular catheter introduction needle FDA UDI
- Device Name
- 18G x 20cm echogenic tip FDA UDI
- Model / Reference
- U01A030418 FDA UDI
- Description
- 18G x 20cm echogenic tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936881156588 FDA UDI
- FDA Product Code
- GBO FDA UDI
- GMDN Term
- Vascular catheter introduction needle FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Vascular catheter introduction needle
Nephrostomy introduction Needle Bevel Tip by Well Lead Medical Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vascular catheter introduction needle.
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- Safety Excalibur Introducer System with Punctur-Guard — Bard Access Systems, Inc. · Class II
- Procedure Products Needles — PROCEDURE PRODUCTS, INC. · Class II
- Cook — COOK INCORPORATED · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- BD Potts-Cournand 18Gx2.05in — BECTON DICKINSON AND COMPANY · Class II
- Procedure Products needles — PROCEDURE PRODUCTS, INC. · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Well Lead Medical Co., Ltd
Sources (1)
- FDA UDI 01ef6782-be4b-439c-a932-1bb77cf611b2 33 fields · synced May 30, 2026