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Hopkins

FDA UDI

Class II (US FDA UDI)

by Karl Storz GmbH & Co. KG

Identity

Trade Name
HOPKINS FDA UDI
Generic Name
Rigid optical cystourethroscope FDA UDI
Device Name
HOPKINS® Telescope 30°, 4 mm, 30 cm FDA UDI
Model / Reference
27005BA FDA UDI
Description
HOPKINS® Telescope 30°, 4 mm, 30 cm FDA UDI

Identifiers

Primary DI / UDI-DI
04048551001066 FDA UDI
FDA Product Code
FAJ FDA UDI
GMDN Term
Rigid optical cystourethroscope 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Rigid optical cystourethroscope

A comprehensive endoscope used for visual examination and treatment of the bladder, urethra, and prostate region. It is inserted through the natural urinary orifice during an endourologic procedure.

Similar devices

Also classified as Rigid optical cystourethroscope.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Karl Storz GmbH & Co. KG

Sources (1)

  • FDA UDI 4e11f8b2-3ccc-4427-a66a-f5074d10fcf4 33 fields · synced Jul 21, 2026