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Uscope

FDA UDI

Class II (US FDA UDI)

by Zhuhai Pusen Medical Technology Co, Ltd

Identity

Trade Name
Uscope FDA UDI
Generic Name
Flexible video ureteroscope, reusable FDA UDI
Device Name
This instrument has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. FDA UDI
Model / Reference
UE3011 FDA UDI
Description
This instrument has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. FDA UDI

Identifiers

Primary DI / UDI-DI
06971176280036 FDA UDI
510(k) Number
K171076 FDA UDI
FDA Product Code
FGB FDA UDI
GMDN Term
Flexible video ureteroscope, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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

No

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Flexible video ureteroscope, reusable

Uscope by Zhuhai Pusen Medical Technology Co, Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible video ureteroscope, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zhuhai Pusen Medical Technology Co, Ltd

Sources (1)

  • FDA UDI 97999be1-1c97-4024-8f11-9f498521f53d 35 fields · synced May 31, 2026