FDA.reportPublic FDA data

INKA

Primary DI
09348811109095
Brand
INKA
Company
The Trustee for KAISER FAMILY TRUST
Model
31286.26
Catalog number
31286.26
Device description
ROSEN Round Knife 45° angled blade Ø 2.5mm blade 16cm
Published
2025-11-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JYOKnife, Ear

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348811109095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348811109095093488111090959348811109095

GMDN Terms#

Term, Definition table
TermDefinition
Ear knifeA hand-held manual surgical instrument intended to cut and dissect tissues of the ear during a surgical intervention. It is typically designed as a one-piece instrument with a sharp, single-edged, cutting blade at the distal end; this is normally quite small and may be of various shapes, and has a long slender shaft with a handle at the proximal end. It is normally 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
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09348811101655INKA30522.192026-04-24
09348811102522INKA36239.212026-04-24
09348811103796INKA33945.022026-04-24
09348811104236INKA31559.092026-04-24
09348811104595INKA31572.09 BL2026-04-24
09348811104908INKA33261.252026-04-24
09348811104915INKA33261.302026-04-24
09348811104953INKA33264.252026-04-24
09348811105653INKA33244.302026-04-24
09348811105707INKA33245.302026-04-24
09348811109408INKA31405.352026-04-24
09348811109415INKA31405.402026-04-24
09348811111975INKA31252.202026-04-24
09348811114891INKA31683.09 BL2026-04-24
09348811115829INKA33866.212026-04-24
09348811116673INKA33125.022026-04-24
09348811172099INKA31576.062026-04-24
09348811099037INKA31367.062026-04-10
09348811150233INKA31286.26 RD2026-04-10
09348811003119INKA10415.182026-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770419135Bausch + LombBausch & Lomb IncorporatedJYO2026-05-11
00757770434268Bausch + LombBausch & Lomb IncorporatedJYO2026-05-11
20757770457568Bausch + LombBausch & Lomb IncorporatedJYO2026-04-30
20757770457551Bausch + LombBausch & Lomb IncorporatedJYO2026-04-29
09348811150233INKAThe Trustee for KAISER FAMILY TRUSTJYO2026-04-10
09348811150134INKAThe Trustee for KAISER FAMILY TRUSTJYO2026-03-16
00757770712281Bausch + LombBausch & Lomb IncorporatedJYO2026-02-11
00757770714056Bausch + LombBausch & Lomb IncorporatedJYO2026-02-11
09348811108906INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811149923INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811150141INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811150189INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811150196INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811111746INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-24
09348811111753INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-24
09348811111760INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-24
09348811111777INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-24
09348811108869INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811108913INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811109040INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811109057INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811109064INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811109071INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811109088INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811109170INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811109187INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811149909INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
00757770676316Bausch + LombBausch & Lomb IncorporatedJYO2025-11-14
00844505014694SKULL BASEGrace Medical, Inc.JYO2025-09-26
00840183530259BR Surgical, LLCBR Surgical, LLCJYO2025-09-10