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Sklar®

FDA UDI

Class II (US FDA UDI)

by Sklar Corporation

Identity

Trade Name
Sklar® FDA UDI
Generic Name
Urethrotome FDA UDI
Device Name
OTIS URETHROTOME 5PC SET FDA UDI
Model / Reference
85-2400 FDA UDI
Description
OTIS URETHROTOME 5PC SET FDA UDI

Identifiers

Primary DI / UDI-DI
10649111188558 FDA UDI
510(k) Number
K012660 FDA UDI
FDA Product Code
EZO FDA UDI
GMDN Term
Urethrotome FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4770 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: Urethrotome

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

Similar devices

Also classified as Urethrotome.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sklar Corporation

Sources (1)

  • FDA UDI fa921844-9fe1-4e55-83d8-e6a2f093ac69 34 fields · synced May 30, 2026