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: DISP ADULT RING-TIP EAR CUR 12 FDA UDI
Model / Reference: 96-1015 FDA UDI
Description: DISP ADULT RING-TIP EAR CUR 12 FDA UDI

Identifiers

Primary DI / UDI-DI: 40649111212834 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

Category: Endaural surgical curette, single-use

This device is a slender, hand-held, manual surgical instrument designed for procedures during middle ear surgery (e.g., removal of the superior bony rim), and may in addition be used for scraping within the ear canal (e.g., removing wax).

The instrument has a serrated or blunt loop, or hook, at its distal end that may be straight, slightly curved, or angled; it is typically made of high-grade stainless steel. This is a single-use device.

For more information about this medical device, please refer to the manufacturer's website or contact their customer support team.

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Also classified as Endaural surgical curette, single-use.

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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

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Manufacturer

Manufacturer: Sklar Corporation

Sources (1)

FDA UDI c2ecfdeb-8a77-4b32-b160-a384a3cca023 33 fields · synced Jul 24, 2026