Percutaneous Nephrostomy Dilator

FDA UDI

Class I (US FDA UDI)

by Well Lead Medical Co., Ltd

Identity

Trade Name: Percutaneous Nephrostomy Dilator FDA UDI
Generic Name: Endoscopic-access dilator, reusable FDA UDI
Device Name: 12Fr x 20cm FDA UDI
Model / Reference: U02E011220 FDA UDI
Description: 12Fr x 20cm FDA UDI

Identifiers

Primary DI / UDI-DI: 06936881156724 FDA UDI
FDA Product Code: GCC FDA UDI
GMDN Term: Endoscopic-access dilator, reusable 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscopic-access dilator, reusable

Percutaneous Nephrostomy Dilator by Well Lead Medical Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 16154eb9-8aba-4bc4-9b5f-163a1a249065 33 fields · synced May 30, 2026