FDA.reportPublic FDA data

Sklar

Primary DI
40649111017811
Brand
Sklar
Company
SKLAR CORPORATION
Model
21-177
Device description
BILLEAU EAR LOOP MEDIUM BX12
Published
2019-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JYGCURETTE, EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYGCurette, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40649111017811PrimaryGS10
00649111017813Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4064911101781140649111017811
00649111017813006491110178136491110178130649111017813

GMDN Terms#

Term, Definition table
TermDefinition
Endaural curette, single-useA slender, hand-held, manual surgical instrument designed for scraping within the ear canal (e.g., removing wax), and for procedures during middle ear surgery (e.g., removal of the superior bony rim). 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
006966006
Device count
12
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10649111501326Sklar Instruments31-40742026-03-12
10649111294235Sklar®67-10202016-10-07
40649111231422Sklar Instruments96-11302025-11-11
40649111233150Sklar Instruments96-11402025-11-11
40649111233501Sklar Instruments96-11422025-11-11
40649111233785Sklar Instruments96-11442025-11-11
40649111234102Sklar Instruments96-11462025-11-11
50649111095045Sklar Instruments94-02902025-06-15
50649111232921Sklar Instruments941-01922025-06-15
50649111344174Sklar Instruments941-09182025-06-15
50649111400115Sklar Instruments941-12592025-06-15
50649111400122Sklar Instruments941-12602025-06-15
50649111400139Sklar Instruments941-12612025-06-15
50649111447752Sklar Instruments941-15562025-06-15
50649111447912Sklar Instruments941-16132025-06-15
50649111469907Sklar Instruments941-13202025-06-15
50649111050402Sklar Instruments96-25162025-05-29
50649111050594Sklar Instruments96-25172025-05-29
50649111081109Sklar Instruments96-26802025-05-29
50649111081499Sklar Instruments96-26822025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776418069MillenniumAvalign Technologies, Inc.JYG2026-03-23
00192896111783Buck Ear CuretteSONTEC INSTRUMENTS, INC.JYG2026-02-26
00192896111790Buck Ear CuretteSONTEC INSTRUMENTS, INC.JYG2026-02-26
00192896111806Buck Ear CuretteSONTEC INSTRUMENTS, INC.JYG2026-02-26
00192896111813Buck Ear CuretteSONTEC INSTRUMENTS, INC.JYG2026-02-26
00192896111820Buck Ear CuretteSONTEC INSTRUMENTS, INC.JYG2026-02-26
00192896111837Buck Ear CuretteSONTEC INSTRUMENTS, INC.JYG2026-02-26
00190776416478MillenniumAvalign Technologies, Inc.JYG2026-02-16
00190776416485MillenniumAvalign Technologies, Inc.JYG2026-02-16
00757770672080Bausch + LombBausch & Lomb IncorporatedJYG2025-12-12
04250676716422Buck ear curetteSpiggle & Theis Medizintechnik GmbHJYG2025-09-25
04250381855461Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381855478Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381855973Spoon curetteSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381855980Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381855997Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856000Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856017Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856024Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856031Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856086Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856093Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856109Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856116Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381863329Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381863336Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381863343Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381863350Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381862490Tisch micro curetteSpiggle & Theis Medizintechnik GmbHJYG2025-09-11
00190776409357MillenniumAvalign Technologies, Inc.JYG2025-08-25