Sklar

FDA UDI

Class I (US FDA UDI)

by Sklar Corporation

Identity

Trade Name: Sklar FDA UDI
Generic Name: Endaural surgical curette, single-use FDA UDI
Device Name: CURETTE EXCA D/E 1-3 1.5X2.5MM FDA UDI
Model / Reference: 21-190 FDA UDI
Description: CURETTE EXCA D/E 1-3 1.5X2.5MM FDA UDI

Identifiers

Primary DI / UDI-DI: 40649111398781 FDA UDI
FDA Product Code: JYG FDA UDI
GMDN Term: Endaural surgical curette, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4420 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Endaural surgical curette, single-use

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

Similar devices

Also classified as Endaural surgical curette, single-use.

Instrapac — ROBINSON HEALTHCARE LIMITED · Class I
Instrapac — ROBINSON HEALTHCARE LIMITED · Class I
McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
ENT POCKET LIGHT — C F M TECHNOLOGIES INC · Class I
MediChoice — OWENS & MINOR DISTRIBUTION, INC. · Class I
Medline — MEDLINE INDUSTRIES, INC. · Class I
MediChoice — OWENS & MINOR DISTRIBUTION, INC. · Class I
McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Sklar Corporation

Sources (1)

FDA UDI 04b5c341-d26f-4279-8db9-fe303a8e1b3a 33 fields · synced May 30, 2026