FDA.reportPublic FDA data

INKA

Primary DI
09348811149923
Brand
INKA
Company
The Trustee for KAISER FAMILY TRUST
Model
31287.25
Catalog number
31287.25
Device description
ROSEN Round Knife 90° angled blade Ø 2.5mm blade 16cm
Published
2025-12-02
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
JYOKnife, Ear

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348811149923PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348811149923093488111499239348811149923

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
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
09348811023018INKA15341.152026-03-16
09348811023667INKA15423.112026-03-16
09348811103338INKA30420.142026-03-16
09348811111906INKA31252.032026-03-16
09348811112002INKA31255.082026-03-16
09348811150134INKA31270.16 RD2026-03-16
09348811151254INKA18261.142026-03-16
09348811103321INKA30420.082026-03-09
09348811150288INKA31241.16 RD2026-03-09
09348811150356INKA31252.12 RD2026-03-09
09348811000873INKA10236.3010236.302026-02-13
09348811000897INKA10237.1510237.152026-02-13
09348811000903INKA10237.1710237.172026-02-13
09348811000927INKA10237.1410237.142026-02-13
09348811000934INKA10237.2010237.202026-02-13
09348811000941INKA10237.2310237.232026-02-13
09348811000958INKA10237.2810237.282026-02-13
09348811000965INKA10237.3010237.302026-02-13
09348811000972INKA10237.3310237.332026-02-13
09348811000989INKA10237.3610237.362026-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
00757770676316Bausch + LombBausch & Lomb IncorporatedJYO2025-11-14
00844505014694SKULL BASEGrace Medical, Inc.JYO2025-09-26
00757770636235Bausch + LombBausch & Lomb IncorporatedJYO2025-08-13
00757770668564Bausch + LombBausch & Lomb IncorporatedJYO2025-08-13
00757770672103Bausch + LombBausch & Lomb IncorporatedJYO2025-08-13
00757770682584Bausch + LombBausch & Lomb IncorporatedJYO2025-08-13
00757770682591Bausch + LombBausch & Lomb IncorporatedJYO2025-08-13
00757770683611Bausch + LombBausch & Lomb IncorporatedJYO2025-08-13
00757770683628Bausch + LombBausch & Lomb IncorporatedJYO2025-08-13
00757770404001Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05
00757770405206Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05
00757770407590Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05
00757770407712Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05
00757770408634Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05
00757770409723Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05
00757770410767Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05
00757770413980Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05
00757770414963Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05
00757770416578Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05