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Clearvision

FDA UDI

Class II (US FDA UDI)

by Karl Storz GmbH & Co. KG

Identity

Trade Name
CLEARVISION FDA UDI
Generic Name
Surgical irrigation/aspiration handpiece, reusable FDA UDI
Device Name
Irrigation Sheath 0° for CLEARVISION® FDA UDI
Model / Reference
28163RSA FDA UDI
Description
Irrigation Sheath 0° for CLEARVISION® FDA UDI

Identifiers

Primary DI / UDI-DI
04048551102145 FDA UDI
FDA Product Code
GWG FDA UDI
GMDN Term
Surgical irrigation/aspiration handpiece, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1480 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical irrigation/aspiration handpiece, reusable

Clearvision by Karl Storz GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical irrigation/aspiration handpiece, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 8c436eb7-e7e9-4a39-ad50-3e8e169f2ad5 33 fields · synced Jun 8, 2026