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Sklar®

FDA UDI

Class II (US FDA UDI)

by Sklar Corporation

Identity

Trade Name
Sklar® FDA UDI
Generic Name
Open-surgery electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
Device Name
SKLARTECH 5000 SINGLE VALVE IRRIGATION SYSTEM FDA UDI
Model / Reference
31-2259 FDA UDI
Description
SKLARTECH 5000 SINGLE VALVE IRRIGATION SYSTEM FDA UDI

Identifiers

Primary DI / UDI-DI
10649111344664 FDA UDI
FDA Product Code
GCX FDA UDI
GMDN Term
Open-surgery electrosurgical handpiece/electrode, monopolar, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6740 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

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Open-surgery electrosurgical handpiece/electrode, monopolar, reusable

Sklar® by Sklar Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Open-surgery electrosurgical handpiece/electrode, monopolar, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sklar Corporation

Sources (1)

  • FDA UDI 1c7d4a1d-d7e9-4081-bbfb-81684c23d3fb 33 fields · synced May 30, 2026