FDA.reportPublic FDA data

INKA

Primary DI
09348811100542
Brand
INKA
Company
The Trustee for KAISER FAMILY TRUST
Model
30258.00
Device description
BUCK Ear Curette sz:00 (2.2mm) blunt angled tip 14cm
Published
2026-07-31
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
false

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
09348811100542PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348811100542093488111005429348811100542

GMDN Terms#

Term, Definition table
TermDefinition
Endaural surgical curette, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
742109993
Device count
1
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09348811083098INKA20706.182026-07-31
09348811102645INKA31351.172026-07-31
09348811102669INKA31352.172026-07-31
09348811103291INKA36429.052026-07-31
09348811109194INKA31278.162026-07-31
09348811111951INKA31252.122026-07-31
09348811111982INKA31255.042026-07-31
09348811112026INKA31255.152026-07-31
09348811114846INKA31657.132026-07-31
09348811150257INKA31287.20 RD2026-07-31
09348811155320INKA31255.032026-07-31
09348811155337INKA31255.122026-07-31
09348811109798INKA30370.192026-07-30
09348811149756INKA31254.062026-07-30
09348811146069INKA33343.202026-07-03
09348811022066INKA31654.082026-06-02
09348811105868INKA31740.082026-06-02
09348811111944INKA31252.102026-06-02
09348811115461INKA36187.132026-06-02
09348811148858INKA30149.052026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422295MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422356MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422363MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422370MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422387MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422394MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776403331MillenniumAvalign Technologies, Inc.JYG2026-07-21
00190776400637MillenniumAvalign Technologies, Inc.JYG2026-07-19
00190776395469MillenniumAvalign Technologies, Inc.JYG2026-07-14
09348811100603INKAThe Trustee for KAISER FAMILY TRUSTJYG2026-05-29
09348811100825INKAThe Trustee for KAISER FAMILY TRUSTJYG2026-05-29
09348811100832INKAThe Trustee for KAISER FAMILY TRUSTJYG2026-05-29
09348811100559INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100566INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100573INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100818INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100849INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100856INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
20888277660196MEDLINEMEDLINE INDUSTRIES, INC.JYG2024-11-22
20888277660233MEDLINEMEDLINE INDUSTRIES, INC.JYG2024-11-22
20888277660240MEDLINEMEDLINE INDUSTRIES, INC.JYG2024-11-05
08904461000321OSSEOUS Rosen InserterEON MEDITECH PRIVATE LIMITEDJYG2024-07-04
08906039319620OSSEOUS Jobson Horne Probe-RoundEON MEDITECH PRIVATE LIMITEDJYG2024-07-04
08906039319637OSSEOUS Jobson Horne Probe-OvalEON MEDITECH PRIVATE LIMITEDJYG2024-07-04
08906039319644OSSEOUS Cerumen hookEON MEDITECH PRIVATE LIMITEDJYG2024-07-04
08906039319668OSSEOUS Myringotomy knifeEON MEDITECH PRIVATE LIMITEDJYG2024-07-04
20888277660202MedlineMEDLINE INDUSTRIES, INC.JYG2024-05-01
20888277660219MedlineMEDLINE INDUSTRIES, INC.JYG2024-05-01
20888277660226MedlineMEDLINE INDUSTRIES, INC.JYG2024-05-01
20888277660257MedlineMEDLINE INDUSTRIES, INC.JYG2024-05-01